Individual Differences in the Response to Drugs

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Preliminary Investigation of Individual Differences in Subjective Responses to D-amphetamine, Alcohol, and Delta-9-tetrahydrocannabinol

Conditions
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Healthy

Intervention / Treatment
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* Drug: THC
* Drug: AMP
* Drug: ALC
* Drug: Placebo capsules
* Drug: Placebo beverage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMP, ALC, THC or Placebo 1<br>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<br>* 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.<br>* Other names: delta-9-tetrahydrocannabinol;Drug: AMP<br>* 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.<br>* Other names: d-Amphetamine;Drug: ALC<br>* 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.<br>* Other names: Alcohol;Drug: Placebo capsules<br>* 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.<br>* Other names: Sugar Pills;Drug: Placebo beverage<br>* 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.<br>|
| Experimental: AMP, ALC, THC or Placebo 2<br>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<br>* 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.<br>* Other names: delta-9-tetrahydrocannabinol;Drug: AMP<br>* 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.<br>* Other names: d-Amphetamine;Drug: ALC<br>* 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.<br>* Other names: Alcohol;Drug: Placebo capsules<br>* 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.<br>* Other names: Sugar Pills;Drug: Placebo beverage<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in General Drug Effects (Drug Effects Questionnaire) at 30 Minutes After Capsule 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. | Measured 15 minutes prior to capsule administration and 30 minutes after capsule administration and before drink administration | 
| Change in General Drug Effects (Drug Effects Questionnaire) at 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. | Measured 15 minutes prior to capsule administration and 30 minutes after drink administration. | 
| Change in General Drug Effects (Drug Effects Questionnaire) at 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. | Measured 15 minutes prior to capsule administration and 90 minutes after drink administration. | 
| Change in General Drug Effects (Drug Effects Questionnaire) at 120 Minutes After Drink Administraion | 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. | Measured 15 minutes prior to capsule administration and 120 minutes after drink administration. | 
| Change in General Drug Effects (Drug Effects Questionnaire) at 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. | Measured 15 minutes prior to capsule administration and 150 minutes after drink administration. | 
| Change in General Drug Effects (Drug Effects Questionnaire) at 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. | Measured 15 minutes prior to capsule administration and 180 minutes after drink administration. | 
| Change in General Drug Effects (Drug Effects Questionnaire) at 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. | Measured 15 minutes prior to capsule administration and 210 minutes after drink administration. | 
| Change in Specific Drug Effects (Addiction Research Center Inventory) at 30 Minutes After Capsule 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. | Measured 15 minutes prior to capsule administration and 30 minutes after capsule administration and before drink administration | 
| Change in Specific Drug Effects (Addiction Research Center Inventory) at 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. | Measured 15 minutes prior to capsule administration and 30 minutes after drink administration | 
| Change in Specific Drug Effects (Addiction Research Center Inventory) at 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. | Measured 15 minutes prior to capsule administration and 90 minutes after drink administration | 
| Change in Specific Drug Effects (Addiction Research Center Inventory) at 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. | Measured 15 minutes prior to capsule administration and 120 minutes after drink administration | 
| Change in Specific Drug Effects (Addiction Research Center Inventory) at 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. | Measured 15 minutes prior to capsule administration and 150 minutes after drink administration | 
| Change in Specific Drug Effects (Addiction Research Center Inventory) at 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. | Measured 15 minutes prior to capsule administration and 180 minutes after drink administration | 
| Change in Specific Drug Effects (Addiction Research Center Inventory) at 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. | Measured 15 minutes prior to capsule administration and 210 minutes after drink administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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THC, Subjective Effects, Alcohol, Amphetamine, Personality