Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Individual Differences in the Response to Drugs (TDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02485158
Recruitment Status : Completed
First Posted : June 30, 2015
Results First Posted : November 29, 2016
Last Update Posted : November 29, 2016
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition Healthy
Interventions Drug: THC
Drug: AMP
Drug: ALC
Drug: Placebo capsules
Drug: Placebo beverage
Enrollment 28
Recruitment Details Healthy social drinkers were recruited from the Chicago area through flyers and online advertisements, from June 2013 through February 2014.
Pre-assignment Details  
Arm/Group Title Healthy Adult Volunteers
Hide Arm/Group Description 24 healthy adult volunteers completed a 6 session within-subject, double-blind, placebo-controlled trial. At three of these sessions, they received one of three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At each session, they received a capsule and a drink. At the amphetamine drug session, they received a capsule containing d-amphetamine and a placebo beverage. At the THC drug session, they received a capsule containing THC and a placebo beverage. At the alcohol drug session they received a placebo capsule and a beverage containing alcohol. At the three matched placebo sessions, both the capsule and the beverage were placebo.
Period Title: Overall Study
Started 28
Completed 24
Not Completed 4
Reason Not Completed
Withdrawal by Subject             3
expected drug side effect             1
Arm/Group Title Healthy Adult Volunteers
Hide Arm/Group Description All healthy adult volunteers completed a 6 session within-subject, double-blind, placebo-controlled trial. At three of these sessions, they received one of three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At each session, they received a capsule and a drink. At the amphetamine drug session, they received a capsule containing d-amphetamine and a placebo beverage. At the THC drug session, they received a capsule containing THC and a placebo beverage. At the alcohol drug session they received a placebo capsule and a beverage containing alcohol. At the three matched placebo sessions, both the capsule and the beverage were placebo.
Overall Number of Baseline Participants 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants
24.6  (2.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
16
  57.1%
Male
12
  42.9%
1.Primary Outcome
Title Change in General Drug Effects (Drug Effects Questionnaire) at 30 Minutes After Capsule Administration
Hide Description Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 30 minutes after capsule administration and before drink administration. Baseline was measure 15 minutes prior to capsule administration.
Time Frame Measured 15 minutes prior to capsule administration and 30 minutes after capsule administration and before drink administration
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed all sessions
Arm/Group Title AMP Arm ALC Arm THC Arm AMP Placebo Arm ALC Placebo Arm THC Placebo Arm
Hide Arm/Group Description:
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
Overall Number of Participants Analyzed 24 24 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
DEQ Feel 4.79  (7.22) 12.83  (18.78) 11.08  (21.09) 12.17  (19.90) 9.38  (11.12) 4.5  (13.16)
DEQ Like 16.08  (27.47) 18.67  (28.81) 11.75  (21.84) 9.0  (18.42) 10.04  (17.90) 9.67  (24.14)
DEQ Dislike 4.21  (9.43) 11.71  (20.35) 12.38  (23.77) 10.71  (18.75) 11.0  (20.60) 0.83  (2.24)
DEQ High 3.29  (6.06) 8.83  (16.31) 10.58  (21.85) 6.96  (18.44) 5.5  (10.43) 3.67  (9.40)
DEQ More 14.21  (25.26) 13.5  (25.24) 6.54  (13.71) 5.63  (12.59) 3.71  (7.66) 11.0  (25.32)
2.Primary Outcome
Title Change in General Drug Effects (Drug Effects Questionnaire) at 30 Minutes After Drink Administration
Hide Description Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 30 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.
Time Frame Measured 15 minutes prior to capsule administration and 30 minutes after drink administration.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed all sessions
Arm/Group Title AMP Arm ALC Arm THC Arm AMP Placebo Arm ALC Placebo Arm THC Placebo Arm
Hide Arm/Group Description:
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
Overall Number of Participants Analyzed 24 24 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
DEQ Feel 43.42  (29.53) 76.83  (20.01) 38.25  (33.45) 21.58  (19.52) 17.83  (22.56) 18.63  (20.69)
DEQ Like 53.88  (34.49) 45.08  (28.43) 28.75  (30.05) 16.63  (22.89) 14.38  (20.78) 25.29  (28.76)
DEQ Dislike 15.71  (22.76) 43.96  (28.96) 25.63  (35.03) 17.71  (23.32) 16.68  (26.83) 15.79  (20.66)
DEQ High 30.5  (27.78) 50.38  (32.15) 31.75  (35.00) 12.54  (18.09) 11.5  (21.80) 12.96  (20.22)
DEQ More 42.17  (35.27) 24.75  (32.67) 17.46  (25.18) 10.96  (19.14) 10.0  (18.32) 18.96  (28.97)
3.Primary Outcome
Title Change in General Drug Effects (Drug Effects Questionnaire) at 90 Minutes After Drink Administration
Hide Description Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 90 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.
Time Frame Measured 15 minutes prior to capsule administration and 90 minutes after drink administration.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed all sessions
Arm/Group Title AMP Arm ALC Arm THC Arm AMP Placebo Arm ALC Placebo Arm THC Placebo Arm
Hide Arm/Group Description:
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
Overall Number of Participants Analyzed 24 24 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
DEQ Feel 34.92  (24.75) 61.21  (24.02) 31.54  (31.41) 16.46  (18.97) 12.75  (18.74) 13.17  (19.05)
DEQ Like 55.67  (31.45) 29.92  (28.57) 20.08  (26.32) 10.42  (18.22) 11.38  (19.35) 13.25  (22.87)
DEQ Dislike 16.54  (21.60) 50.46  (26.47) 23.25  (29.72) 17.54  (26.16) 15.33  (24.85) 15.96  (24.91)
DEQ High 27.92  (24.57) 41.83  (30.74) 29.21  (32.78) 6.83  (12.47) 7.25  (13.50) 7.58  (12.65)
DEQ More 50.21  (36.06) 25.88  (35.11) 16.54  (23.69) 6.54  (15.33) 7.71  (16.59) 12.88  (21.88)
4.Primary Outcome
Title Change in General Drug Effects (Drug Effects Questionnaire) at 120 Minutes After Drink Administraion
Hide Description Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 120 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.
Time Frame Measured 15 minutes prior to capsule administration and 120 minutes after drink administration.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed all sessions
Arm/Group Title AMP Arm ALC Arm THC Arm AMP Placebo Arm ALC Placebo Arm THC Placebo Arm
Hide Arm/Group Description:
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
Overall Number of Participants Analyzed 24 24 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
DEQ Feel 27.08  (22.38) 43.92  (24.18) 24.08  (29.28) 11.92  (14.26) 7.96  (14.08) 7.88  (14.65)
DEQ Like 43.75  (36.08) 23.79  (25.61) 18  (27.26) 7.04  (13.90) 4.83  (11.49) 8.67  (16.86)
DEQ Dislike 11.92  (19.56) 44.92  (31.37) 19.63  (27.21) 13.38  (22.39) 11.08  (23.89) 8.88  (18.69)
DEQ High 18.88  (21.43) 29.38  (25.77) 21.96  (30.06) 5.04  (8.12) 5.08  (11.20) 4.83  (10.45)
DEQ More 45.38  (34.86) 17.5  (27.95) 9.92  (18.06) 3.13  (5.53) 6.54  (15.59) 9.88  (19.63)
5.Primary Outcome
Title Change in General Drug Effects (Drug Effects Questionnaire) at 150 Minutes After Drink Administration
Hide Description Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 150 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.
Time Frame Measured 15 minutes prior to capsule administration and 150 minutes after drink administration.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed all sessions
Arm/Group Title AMP Arm ALC Arm THC Arm AMP Placebo Arm ALC Placebo Arm THC Placebo Arm
Hide Arm/Group Description:
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
Overall Number of Participants Analyzed 24 24 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
DEQ Feel 19.79  (17.72) 30.83  (22.52) 18.63  (25.28) 5.83  (10.72) 4.63  (10.48) 4.63  (7.80)
DEQ Like 39.5  (34.58) 21.33  (24.74) 11.71  (19.22) 6.74  (14.88) 2.42  (6.76) 4.96  (14.48)
DEQ Dislike 11.25  (20.64) 40.75  (32.31) 17.79  (26.78) 8.09  (21.80) 4.29  (13.84) 6.42  (15.69)
DEQ High 16.33  (18.68) 20.46  (23.70) 14.75  (20.27) 2.87  (4.48) 2.13  (4.83) 1.96  (4.56)
DEQ More 44.08  (34.63) 12.58  (24.39) 9.38  (18.95) 2.87  (10.55) 5.04  (12.75) 6.21  (15.19)
6.Primary Outcome
Title Change in General Drug Effects (Drug Effects Questionnaire) at 180 Minutes After Drink Administration
Hide Description Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 180 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.
Time Frame Measured 15 minutes prior to capsule administration and 180 minutes after drink administration.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed all sessions
Arm/Group Title AMP Arm ALC Arm THC Arm AMP Placebo Arm ALC Placebo Arm THC Placebo Arm
Hide Arm/Group Description:
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
Overall Number of Participants Analyzed 24 24 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
DEQ Feel 16.13  (17.06) 22.21  (19.71) 15.67  (24.63) 3.5  (8.548) 2.08  (5.01) 2.54  (4.59)
DEQ Like 31.08  (34.86) 9.04  (14.29) 7.33  (15.82) 2.54  (11.23) 1.75  (7.56) 4.0  (12.47)
DEQ Dislike 11.54  (25.17) 29.5  (34.28) 16.13  (28.42) 4.25  (17.24) 4.29  (16.80) 4.63  (13.65)
DEQ High 11.67  (15.29) 14.13  (19.36) 11.79  (18.36) 1.63  (4.92) 1.25  (3.30) 1.04  (3.30)
DEQ More 38.38  (34.54) 7.0  (19.77) 10.04  (18.61) 2.46  (10.99) 4.04  (12.22) 5.04  (12.89)
7.Primary Outcome
Title Change in General Drug Effects (Drug Effects Questionnaire) at 210 Minutes After Drink Administration
Hide Description Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 210 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.
Time Frame Measured 15 minutes prior to capsule administration and 210 minutes after drink administration.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed all sessions
Arm/Group Title AMP Arm ALC Arm THC Arm AMP Placebo Arm ALC Placebo Arm THC Placebo Arm
Hide Arm/Group Description:
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
Overall Number of Participants Analyzed 24 24 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
DEQ Feel 11.08  (16.71) 12.88  (15.88) 5.79  (10.91) 2.17  (5.74) 0.96  (2.74) 1.08  (2.75)
DEQ Like 18.38  (31.38) 7.33  (14.62) 4.88  (10.41) 1.96  (7.04) 0.25  (0.74) 4.38  (13.73)
DEQ Dislike 8.54  (24.16) 22.71  (30.79) 6.83  (15.46) 7.46  (23.16) 1.29  (3.82) 4.54  (15.14)
DEQ High 6.25  (9.88) 9.21  (15.84) 4.96  (11.02) 0.33  (1.05) 0.83  (1.76) 0.42  (1.32)
DEQ More 32.5  (31.84) 4.54  (17.72) 8.79  (17.04) 2.25  (8.19) 3.83  (12.09) 6.17  (14.65)
8.Primary Outcome
Title Change in Specific Drug Effects (Addiction Research Center Inventory) at 30 Minutes After Capsule Administration
Hide Description Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects. The change in ARCI was assessed by the difference in measurements between baseline and 30 minutes after capsule administration and before drink administration. Baseline was measure 15 minutes prior to capsule administration.
Time Frame Measured 15 minutes prior to capsule administration and 30 minutes after capsule administration and before drink administration
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed all sessions
Arm/Group Title AMP Arm ALC Arm THC Arm AMP Placebo Arm ALC Placebo Arm THC Placebo Arm
Hide Arm/Group Description:
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
Overall Number of Participants Analyzed 24 24 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
ARC A -0.17  (0.92) 0.25  (1.33) -0.04  (1.16) -0.25  (0.61) -0.17  (1.2) 0.54  (0.88)
ARC MBG -0.58  (1.44) -0.29  (1.27) -0.71  (1.88) -0.58  (0.65) -0.67  (1.46) 0.33  (1.37)
ARC LSD 0.13  (0.85) 0.33  (0.82) 0.38  (1.69) 0.13  (0.99) 0.08  (0.97) -0.17  (0.64)
ARC BG -0.46  (1.02) -0.75  (1.67) -0.79  (2.0) -1.17  (1.52) -0.92  (1.21) 0.25  (1.03)
ARC PCAG 0.58  (1.21) 1.29  (2.39) 2.92  (2.73) 1.96  (2.44) 0.92  (1.61) 0.42  (1.02)
ARC M 0.08  (1.06) 0.83  (1.81) 0.42  (1.32) 0.5  (1.25) 0.33  (1.05) 0.42  (1.18)
9.Primary Outcome
Title Change in Specific Drug Effects (Addiction Research Center Inventory) at 30 Minutes After Drink Administration
Hide Description Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects. The change in ARCI was assessed by the difference in measurements between baseline and 30 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.
Time Frame Measured 15 minutes prior to capsule administration and 30 minutes after drink administration
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed all sessions
Arm/Group Title AMP Arm ALC Arm THC Arm AMP Placebo Arm ALC Placebo Arm THC Placebo Arm
Hide Arm/Group Description:
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
Overall Number of Participants Analyzed 24 24 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
ARC A 2.88  (2.80) 1.92  (2.64) 0.17  (0.96) 0  (0.93) -0.33  (1.61) 0.71  (1.40)
ARC MBG 3.71  (4.59) 1.38  (4.79) -0.54  (3.04) 0  (1.77) -1.17  (2.75) 0.88  (3.26)
ARC LSD 1.13  (2.03) 2.63  (2.32) 1.54  (2.47) 0.33  (1.09) 0.29  (1.12) 0.13  (1.23)
ARC BG 1.63  (2.28) -0.88  (3.00) -1.38  (1.64) -0.83  (1.31) -0.96  (1.99) 0.04  (1.46)
ARC PCAG -1  (1.89) 3.71  (4.29) 2.96  (3.33) 2.25  (3.55) 1.54  (3.24) 1.13  (2.35)
ARC M 3.21  (2.73) 3.42  (2.22) 2.04  (2.56) 0.42  (0.93) 0.29  (1.16) 0.96  (1.78)
10.Primary Outcome
Title Change in Specific Drug Effects (Addiction Research Center Inventory) at 90 Minutes After Drink Administration
Hide Description Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects. The change in ARCI was assessed by the difference in measurements between baseline and 90 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.
Time Frame Measured 15 minutes prior to capsule administration and 90 minutes after drink administration
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed all sessions
Arm/Group Title AMP Arm ALC Arm THC Arm AMP Placebo Arm ALC Placebo Arm THC Placebo Arm
Hide Arm/Group Description:
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
Overall Number of Participants Analyzed 24 24 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
ARC A 2.96  (2.49) 0.29  (2.44) 0  (1.22) -0.33  (0.76) -0.58  (1.28) -0.08  (1.02)
ARC MBG 3.67  (4.86) -0.38  (2.45) -0.83  (2.55) -0.29  (0.86) -1.29  (2.93) -0.13  (0.95)
ARC LSD 1.08  (1.89) 1.79  (1.93) 1.42  (2.69) -0.04  (0.95) 0.29  (1.12) 0.08  (0.93)
ARC BG 2.17  (2.39) -2.54  (2.40) -1.71  (2.03) -1.29  (1.63) -1.13  (1.57) -0.67  (1.46)
ARC PCAG -1.21  (2.17) 6.21  (2.92) 3.54  (3.68) 2.67  (2.96) 1.92  (3.22) 1.58  (1.91)
ARC M 2.63  (2.46) 2.25  (2.51) 2.04  (2.63) 0.42  (0.97) 0.13  (0.80) 0.29  (0.62)
11.Primary Outcome
Title Change in Specific Drug Effects (Addiction Research Center Inventory) at 120 Minutes After Drink Administration
Hide Description Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects.The change in ARCI was assessed by the difference in measurements between baseline and 120 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.
Time Frame Measured 15 minutes prior to capsule administration and 120 minutes after drink administration
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed all sessions
Arm/Group Title AMP Arm ALC Arm THC Arm AMP Placebo Arm ALC Placebo Arm THC Placebo Arm
Hide Arm/Group Description:
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
Overall Number of Participants Analyzed 24 24 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
ARC A 2.17  (2.06) -0.33  (1.34) -0.08  (1.21) -0.17  (0.70) -0.71  (1.37) -0.04  (0.86)
ARC MBG 3.33  (4.35) -1.13  (2.13) -0.96  (2.60) -0.125  (0.85) -1.29  (2.97) -0.08  (0.65)
ARC LSD 0.38  (1.93) 0.79  (1.28) 1  (2.83) -0.13  (1.15) 0.04  (1.16) -0.08  (0.93)
ARC BG 1.67  (2.12) -2.04  (1.73) -1.54  (1.64) -1  (1.35) -0.83  (1.55) -0.38  (1.58)
ARC PCAG -1.08  (2.02) 5.46  (2.93) 2.88  (3.49) 1.71  (2.65) 1.63  (2.76) 1.08  (1.98)
ARC M 1.83  (2.46) 1.08  (1.56) 1.42  (2.04) 0.25  (0.85) -0.04  (0.86) 0.17  (0.56)
12.Primary Outcome
Title Change in Specific Drug Effects (Addiction Research Center Inventory) at 150 Minutes After Drink Administration
Hide Description Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects.The change in ARCI was assessed by the difference in measurements between baseline and 150 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.
Time Frame Measured 15 minutes prior to capsule administration and 150 minutes after drink administration
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed all sessions
Arm/Group Title AMP Arm ALC Arm THC Arm AMP Placebo Arm ALC Placebo Arm THC Placebo Arm
Hide Arm/Group Description:
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
Overall Number of Participants Analyzed 24 24 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
ARC A 2.29  (2.61) -0.54  (1.14) -0.17  (1.63) -0.13  (0.69) -0.54  (1.47) -0.08  (0.83)
ARC MBG 2.96  (4.39) -1.54  (1.96) -0.96  (2.39) 0.13  (0.76) -1.25  (2.88) -0.08  (0.88)
ARC LSD 0.5  (1.59) 0.79  (1.35) 0.58  (2.22) 0.09  (1.08) -0.13  (1.03) -0.17  (0.82)
ARC BG 1.75  (2.31) -2.04  (1.65) -1.29  (1.86) -0.43  (1.31) -0.67  (1.24) -0.42  (1.28)
ARC PCAG -1  (1.64) 5.46  (2.95) 2.58  (3.16) 0.65  (2.17) 1.58  (2.96) 0.79  (1.79)
ARC M 1.54  (1.91) 0.75  (1.33) 0.83  (1.83) 0.22  (0.74) -0.21  (0.78) 0.08  (0.41)
13.Primary Outcome
Title Change in Specific Drug Effects (Addiction Research Center Inventory) at 180 Minutes After Drink Administration
Hide Description Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects.The change in ARCI was assessed by the difference in measurements between baseline and 180 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.
Time Frame Measured 15 minutes prior to capsule administration and 180 minutes after drink administration
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed all sessions
Arm/Group Title AMP Arm ALC Arm THC Arm AMP Placebo Arm ALC Placebo Arm THC Placebo Arm
Hide Arm/Group Description:
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
Overall Number of Participants Analyzed 24 24 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
ARC A 1.58  (2.26) -0.75  (1.19) -0.21  (1.44) -0.04  (0.91) -0.33  (1.69) -0.17  (1.13)
ARC MBG 1.92  (4.03) -1.29  (1.88) -0.67  (2.37) 0.33  (1.24) -1.08  (3.01) -0.17  (0.82)
ARC LSD 0.46  (1.91) 0.54  (1.02) 0.54  (1.82) 0.04  (1.04) -0.04  (0.81) 0.04  (0.95)
ARC BG 1.13  (2.15) -1.5  (1.47) -1.29  (1.78) -0.33  (1.13) -0.38  (1.41) -0.29  (1.20)
ARC PCAG -0.46  (1.93) 3.63  (3.01) 2.13  (3.43) 0.21  (2.50) 0.71  (2.73) 0.42  (1.59)
ARC M 1.21  (1.59) 0.08  (1.02) 0.71  (1.94) 0.13  (0.68) -0.13  (0.74) -0.08  (0.28)
14.Primary Outcome
Title Change in Specific Drug Effects (Addiction Research Center Inventory) at 210 Minutes After Drink Administration
Hide Description Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects.The change in ARCI was assessed by the difference in measurements between baseline and 210 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.
Time Frame Measured 15 minutes prior to capsule administration and 210 minutes after drink administration
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed all sessions
Arm/Group Title AMP Arm ALC Arm THC Arm AMP Placebo Arm ALC Placebo Arm THC Placebo Arm
Hide Arm/Group Description:
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
Overall Number of Participants Analyzed 24 24 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
ARC A 1.0  (1.93) -0.71  (1.20) -0.46  (1.06) -0.17  (0.82) -0.54  (1.50) 0.08  (1.21)
ARC MBG 1.38  (3.31) -1.17  (2.08) -0.88  (1.92) 0.13  (1.15) -0.79  (2.95) 0.04  (0.86)
ARC LSD 0.63  (1.79) 0.33  (0.92) 0.54  (1.22) 0.25  (0.90) 1.67  (0.87) 0.04  (1.04)
ARC BG 0.83  (1.61) -1.25  (1.39) -0.83  (1.40) -0.17  (0.82) -0.38  (1.06) -0.13  (1.48)
ARC PCAG -0.29  (2.10) 3.17  (3.17) 1.04  (1.76) -0.29  (1.43) 0.21  (2.55) 0.13  (1.68)
ARC M 0.96  (1.97) 0.08  (0.97) 0.21  (0.72) 0  (0.42) -0.17  (0.70) -0.08  (0.28)
Time Frame During study only (1 Day)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Healthy Adult Volunteers
Hide Arm/Group Description 24 healthy adult volunteers completed a 6 session within-subject, double-blind, placebo-controlled trial. At three of these sessions, they received one of three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At each session, they received a capsule and a drink. At the amphetamine drug session, they received a capsule containing d-amphetamine and a placebo beverage. At the THC drug session, they received a capsule containing THC and a placebo beverage. At the alcohol drug session they received a placebo capsule and a beverage containing alcohol. At the three matched placebo sessions, both the capsule and the beverage were placebo.
All-Cause Mortality
Healthy Adult Volunteers
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Healthy Adult Volunteers
Affected / at Risk (%) # Events
Total   0/28 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Healthy Adult Volunteers
Affected / at Risk (%) # Events
Total   1/28 (3.57%)    
Gastrointestinal disorders   
vomiting from alcohol dose * [1]  1/28 (3.57%)  1
*
Indicates events were collected by non-systematic assessment
[1]
expected possible side effect of alcohol
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Harriet de Wit
Organization: University of Chicago
Phone: 773-702-1537
EMail: hdew@uchicago.edu
Layout table for additonal information
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT02485158     History of Changes
Other Study ID Numbers: IRB13-0534
First Submitted: June 24, 2015
First Posted: June 30, 2015
Results First Submitted: December 17, 2015
Results First Posted: November 29, 2016
Last Update Posted: November 29, 2016