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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

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: THC Drug: AMP Drug: ALC Drug: Placebo capsules Drug: Placebo beverage Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Preliminary Investigation of Individual Differences in Subjective Responses to D-amphetamine, Alcohol, and Delta-9-tetrahydrocannabinol
Study Start Date : July 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Amphetamine

Arm Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.



Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   21 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02485158


Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Harriet de Wit, PhD University of Chicago

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT02485158     History of Changes
Other Study ID Numbers: IRB13-0534
First Posted: June 30, 2015    Key Record Dates
Results First Posted: November 29, 2016
Last Update Posted: November 29, 2016
Last Verified: October 2016

Keywords provided by University of Chicago:
Subjective Effects
Alcohol
Amphetamine
THC
Personality

Additional relevant MeSH terms:
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Amphetamine
Dextroamphetamine
Ethanol
Dronabinol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Stimulants
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors
Hallucinogens
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists