Individual Differences in the Response to Drugs (TDS)

The University of Chicago

Status: Completed

Conditions: Healthy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02485158

IRB13-0534

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 21 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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28 participants in 2 patient groups

AMP, ALC, THC or Placebo 1

Experimental group

Description:

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.

Treatment:

Drug: Placebo beverage

Drug: AMP

Drug: THC

Drug: ALC

Drug: Placebo capsules

AMP, ALC, THC or Placebo 2

Experimental group

Description:

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.

Treatment:

Drug: Placebo beverage

Drug: AMP

Drug: THC

Drug: ALC

Drug: Placebo capsules