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Completed

NCT Number: NCT02485158

Individual Differences in the Response to Drugs

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.

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Key information

Conditions

Age range

21 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

THC

Drug

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 names: delta-9-tetrahydrocannabinol

AMP

Drug

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 names: d-Amphetamine

ALC

Drug

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 names: Alcohol

placebo capsules

Drug

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 names: Sugar Pills

Placebo Beverage

Drug

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

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

Acronym: TDS

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 30, 2015
Registry last updated
Nov 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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