Individual Differences in the Response to Drugs

NCT ID: NCT02485158

Last Updated: 2016-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2013-12-31

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.

Conditions

Healthy

Keywords

Subjective Effects; Alcohol; Amphetamine; THC; Personality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

THC

Intervention Type: 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.

AMP

Intervention Type: 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.

ALC

Intervention Type: 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.

Placebo capsules

Intervention Type: 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.

Placebo beverage

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

THC

Intervention Type: 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.

AMP

Intervention Type: 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.

ALC

Intervention Type: 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.

Placebo capsules

Intervention Type: 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.

Placebo beverage

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

delta-9-tetrahydrocannabinol; d-Amphetamine; Alcohol; Sugar Pills

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harriet de Wit, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

References

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.

Reference Type: DERIVED

PMID: 26513587 (View on PubMed)

Other Identifiers

IRB13-0534

Identifier Type: -

Identifier Source: org_study_id