Individual Differences in the Response to Drugs

NCT02485158 | Completed Results

• 1 other identifier: IRB13-0534
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

Subjective Effects; Alcohol; Amphetamine; THC; Personality

Outcome Measures

Primary Outcomes (14)

• 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

Study Arms (2)

AMP, ALC, THC or Placebo 1

EXPERIMENTAL

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; Drug: AMP; Drug: ALC; Drug: Placebo capsules; Drug: Placebo beverage

AMP, ALC, THC or Placebo 2

EXPERIMENTAL

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; Drug: AMP; Drug: ALC; Drug: Placebo capsules; Drug: Placebo beverage

Interventions

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.

Also known as: delta-9-tetrahydrocannabinol

AMP, ALC, THC or Placebo 1; AMP, ALC, THC or Placebo 2

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.

Also known as: d-Amphetamine

AMP, ALC, THC or Placebo 1; AMP, ALC, THC or Placebo 2

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.

Also known as: Alcohol

AMP, ALC, THC or Placebo 1; AMP, ALC, THC or Placebo 2

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.

Also known as: Sugar Pills

AMP, ALC, THC or Placebo 1; AMP, ALC, THC or Placebo 2

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.

AMP, ALC, THC or Placebo 1; AMP, ALC, THC or Placebo 2

Eligibility Criteria

• Age: 21 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Related Publications (1)

• 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.

  PMID: 26513587 DERIVED

MeSH Terms

Interventions

Dronabinol; Adenosine Monophosphate; Dextroamphetamine; Ethanol

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Alcohols

Results Point of Contact

• Title: Dr. Harriet de Wit
• Organization: University of Chicago

hdew@uchicago.edu

773-702-1537

Study Officials

• Harriet de Wit, PhD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2015
• First Posted: June 30, 2015
• Study Start: July 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 29, 2016
• Results First Posted: November 29, 2016

Record last verified: 2016-10