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Clinical Trials/NCT02485158
NCT02485158
Completed
N/A

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

University of Chicago0 sites28 target enrollmentJuly 2013

Overview

Phase
N/A
Intervention
THC
Conditions
Healthy
Sponsor
University of Chicago
Enrollment
28
Primary Endpoint
Change in General Drug Effects (Drug Effects Questionnaire) at 90 Minutes After Drink Administration
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2013
End Date
December 2013
Last Updated
9 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Arms & Interventions

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.

Intervention: THC

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.

Intervention: AMP

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.

Intervention: ALC

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.

Intervention: Placebo capsules

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.

Intervention: Placebo beverage

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.

Intervention: THC

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.

Intervention: AMP

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.

Intervention: ALC

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.

Intervention: Placebo capsules

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.

Intervention: Placebo beverage

Outcomes

Primary Outcomes

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 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 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 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 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 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 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.

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