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Individual Differences in the Response to Drugs (TDS)

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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

Tracking Information
First Submitted Date  ICMJE June 24, 2015
First Posted Date  ICMJE June 30, 2015
Results First Submitted Date  ICMJE December 17, 2015
Results First Posted Date  ICMJE November 29, 2016
Last Update Posted Date November 29, 2016
Study Start Date  ICMJE July 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2016)
  • Change in General Drug Effects (Drug Effects Questionnaire) at 30 Minutes After Capsule Administration [ Time Frame: Measured 15 minutes prior to capsule administration and 30 minutes after capsule administration and before drink administration ]
    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.
  • Change in General Drug Effects (Drug Effects Questionnaire) at 30 Minutes After Drink Administration [ Time Frame: Measured 15 minutes prior to capsule administration and 30 minutes after drink administration. ]
    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.
  • Change in General Drug Effects (Drug Effects Questionnaire) at 90 Minutes After Drink Administration [ Time Frame: Measured 15 minutes prior to capsule administration and 90 minutes after drink administration. ]
    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.
  • Change in General Drug Effects (Drug Effects Questionnaire) at 120 Minutes After Drink Administraion [ Time Frame: Measured 15 minutes prior to capsule administration and 120 minutes after drink administration. ]
    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.
  • Change in General Drug Effects (Drug Effects Questionnaire) at 150 Minutes After Drink Administration [ Time Frame: Measured 15 minutes prior to capsule administration and 150 minutes after drink administration. ]
    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.
  • Change in General Drug Effects (Drug Effects Questionnaire) at 180 Minutes After Drink Administration [ Time Frame: Measured 15 minutes prior to capsule administration and 180 minutes after drink administration. ]
    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.
  • Change in General Drug Effects (Drug Effects Questionnaire) at 210 Minutes After Drink Administration [ Time Frame: Measured 15 minutes prior to capsule administration and 210 minutes after drink administration. ]
    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.
  • Change in Specific Drug Effects (Addiction Research Center Inventory) at 30 Minutes After Capsule Administration [ Time Frame: Measured 15 minutes prior to capsule administration and 30 minutes after capsule administration and before drink administration ]
    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.
  • Change in Specific Drug Effects (Addiction Research Center Inventory) at 30 Minutes After Drink Administration [ Time Frame: Measured 15 minutes prior to capsule administration and 30 minutes after drink administration ]
    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.
  • Change in Specific Drug Effects (Addiction Research Center Inventory) at 90 Minutes After Drink Administration [ Time Frame: Measured 15 minutes prior to capsule administration and 90 minutes after drink administration ]
    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.
  • Change in Specific Drug Effects (Addiction Research Center Inventory) at 120 Minutes After Drink Administration [ Time Frame: Measured 15 minutes prior to capsule administration and 120 minutes after drink administration ]
    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.
  • Change in Specific Drug Effects (Addiction Research Center Inventory) at 150 Minutes After Drink Administration [ Time Frame: Measured 15 minutes prior to capsule administration and 150 minutes after drink administration ]
    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.
  • Change in Specific Drug Effects (Addiction Research Center Inventory) at 180 Minutes After Drink Administration [ Time Frame: Measured 15 minutes prior to capsule administration and 180 minutes after drink administration ]
    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.
  • Change in Specific Drug Effects (Addiction Research Center Inventory) at 210 Minutes After Drink Administration [ Time Frame: Measured 15 minutes prior to capsule administration and 210 minutes after drink administration ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 29, 2015)
  • Subjective Measures: Change in General Drug Effects (Drug Effects Questionnaire) Over Time [ Time Frame: Measured 15 minutes prior to capsule administration, 30 minutes following capsule administration and before drink administration, and 30, 90, 120, 150, 180, and 210 minutes after drink administration. ]
    Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991)
  • Subjective Measures: Change in Specific Drug Effects (Addiction Research Center Inventory) Over Time [ Time Frame: Measured 15 minutes prior to capsule administration, 30 minutes following capsule administration and before drink administration, and 30, 90, 120, 150, 180, and 210 minutes after drink administration. ]
    Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971)
  • Subjective Measures: Change in Mood (Profile of Mood States) Over Time [ Time Frame: Measured 15 minutes prior to capsule administration, 30 minutes following capsule administration and before drink administration, and 30, 90, 120, 150, 180, and 210 minutes after drink administration. ]
    Mood states will be measured with the Profile of Mood States (McNair et al, 1971)
Change History Complete list of historical versions of study NCT02485158 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2015)
  • Physiological Measures: Change in Heart Rate (Beats per Minute) Over Time [ Time Frame: Measured 15 minutes prior to capsule administration, 30 minutes following capsule administration and before drink administration, and 30, 90, 120, 150, 180, and 210 minutes after drink administration. ]
    Blood pressure will be measured at regular intervals.
  • Physiological Measures: Change in Blood Pressure (mm Hg) Over Time [ Time Frame: Measured 15 minutes prior to capsule administration, 30 minutes following capsule administration and before drink administration, and 30, 90, 120, 150, 180, and 210 minutes after drink administration. ]
    Blood pressure will be measured at regular intervals.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Individual Differences in the Response to Drugs
Official Title  ICMJE A Preliminary Investigation of Individual Differences in Subjective Responses to D-amphetamine, Alcohol, and Delta-9-tetrahydrocannabinol
Brief Summary The purpose of this study is to examine whether individual differences in acute responses to drugs co-vary across three drugs from different drug classes: alcohol, amphetamine and delta-9-tetrahydrocannabinol (THC). The investigators hypothesize that individuals who experience greater rewarding effects from one drug will also experience more rewarding effects from the other drugs.
Detailed Description Here, the investigators aim to investigate whether individuals exhibit similar responses to three different drugs from different classes. This study used a within-subjects design (total N = 24). All subjects received alcohol, amphetamine and delta-9-tetrahydrocannabinol (THC) in a double-blind, double-dummy fashion. Subjects completed six sessions wherein they received either alcohol, amphetamine, or THC, or corresponding placebos, on separate days. Subjects completed questionnaires about mood, general drug effects, and specific drug effects.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: THC
    This is a within-subjects, double-blind, placebo controlled design. We administered oral THC to healthy volunteers to measure their subjective response, which we later compared to their responses to two other drugs.
    Other Name: delta-9-tetrahydrocannabinol
  • Drug: AMP
    This is a within-subjects, double-blind, placebo controlled design. We administered AMP to healthy volunteers to measure their subjective response, which we later compared to their responses to two other drugs.
    Other Name: d-Amphetamine
  • Drug: ALC
    This is a within-subjects, double-blind, placebo controlled design. We administered alcohol to healthy volunteers to measure their subjective response, which we later compared to their responses to two other drugs.
    Other Name: Alcohol
  • Drug: Placebo capsules
    This is a within-subjects, double-blind, placebo controlled design. We administered size 00 gelatin capsules containing dextrose to healthy volunteers as a control for when they received either amphetamine or THC.
    Other Name: Sugar Pills
  • Drug: Placebo beverage
    This is a within-subjects, double-blind, placebo controlled design. We administered a drink containing cranberry juice plus 1% alcohol added as a taste mask.
Study Arms  ICMJE
  • Experimental: AMP, ALC, THC or Placebo 1
    All healthy adult volunteers attended 6 sessions in which they received 20mg AMP, 0.8g/kg ALC, and 7.5mg THC, alternating with three placebo sessions.
    Interventions:
    • Drug: THC
    • Drug: AMP
    • Drug: ALC
    • Drug: Placebo capsules
    • Drug: Placebo beverage
  • Experimental: AMP, ALC, THC or Placebo 2
    All healthy adult volunteers attended 6 sessions in which they received 20mg AMP, 0.8g/kg ALC, and 7.5mg THC, alternating with three placebo sessions.
    Interventions:
    • Drug: THC
    • Drug: AMP
    • Drug: ALC
    • Drug: Placebo capsules
    • Drug: Placebo beverage
Publications * Wardle MC, Marcus BA, de Wit H. A Preliminary Investigation of Individual Differences in Subjective Responses to D-Amphetamine, Alcohol, and Delta-9-Tetrahydrocannabinol Using a Within-Subjects Randomized Trial. PLoS One. 2015 Oct 29;10(10):e0140501. doi: 10.1371/journal.pone.0140501. eCollection 2015.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 6, 2016)
28
Original Actual Enrollment  ICMJE
 (submitted: June 29, 2015)
24
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • English fluency
  • High school education
  • BMI between 19 and 26
  • Individuals who report drinking at least 4 alcoholic drinks on one occasion in the past month

Exclusion Criteria:

  • individuals with a medical condition contraindicating study participation, as determined by our physician
  • individuals regularly using any contraindicated medications
  • individuals with current dependence on any drug or past dependence on alcohol, marijuana or stimulants
  • individuals with a past year DSM-IV Axis I mood, anxiety, eating, or psychotic disorder
  • women who are pregnant, nursing, or planning to become pregnant in the next 3 months
  • individuals who drink more than 10 alcoholic drinks per week
  • individuals who currently use i) any illicit drug weekly or more frequently, ii) stimulant prescription drugs, iii) more than 10 cigarettes per week, and iv) more than 3 cups of coffee per day
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02485158
Other Study ID Numbers  ICMJE IRB13-0534
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Chicago
Study Sponsor  ICMJE University of Chicago
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Harriet de Wit, PhD University of Chicago
PRS Account University of Chicago
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP