Clinical trial NCT02485158: Individual Differences in the Response to Drugs
Official title: A Preliminary Investigation of Individual Differences in Subjective Responses to D-amphetamine, Alcohol, and Delta-9-tetrahydrocannabinol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Subjective Effects
Alcohol
Amphetamine
THC
Personality
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2015-06-30
Enrollment: 28
Sex: ALL
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Change in General Drug Effects (Drug Effects Questionnaire) at 30 Minutes After Capsule Administration
timeFrame: Measured 15 minutes prior to capsule administration and 30 minutes after capsule administration and before drink administration
measure: Change in General Drug Effects (Drug Effects Questionnaire) at 30 Minutes After Drink Administration
timeFrame: Measured 15 minutes prior to capsule administration and 30 minutes after drink administration.
measure: Change in General Drug Effects (Drug Effects Questionnaire) at 90 Minutes After Drink Administration
timeFrame: Measured 15 minutes prior to capsule administration and 90 minutes after drink administration.
measure: Change in General Drug Effects (Drug Effects Questionnaire) at 120 Minutes After Drink Administraion
timeFrame: Measured 15 minutes prior to capsule administration and 120 minutes after drink administration.
measure: Change in General Drug Effects (Drug Effects Questionnaire) at 150 Minutes After Drink Administration
timeFrame: Measured 15 minutes prior to capsule administration and 150 minutes after drink administration.
measure: Change in General Drug Effects (Drug Effects Questionnaire) at 180 Minutes After Drink Administration
timeFrame: Measured 15 minutes prior to capsule administration and 180 minutes after drink administration.
measure: Change in General Drug Effects (Drug Effects Questionnaire) at 210 Minutes After Drink Administration
timeFrame: Measured 15 minutes prior to capsule administration and 210 minutes after drink administration.
measure: Change in Specific Drug Effects (Addiction Research Center Inventory) at 30 Minutes After Capsule Administration
timeFrame: Measured 15 minutes prior to capsule administration and 30 minutes after capsule administration and before drink administration
measure: Change in Specific Drug Effects (Addiction Research Center Inventory) at 30 Minutes After Drink Administration
timeFrame: Measured 15 minutes prior to capsule administration and 30 minutes after drink administration
measure: Change in Specific Drug Effects (Addiction Research Center Inventory) at 90 Minutes After Drink Administration
timeFrame: Measured 15 minutes prior to capsule administration and 90 minutes after drink administration
measure: Change in Specific Drug Effects (Addiction Research Center Inventory) at 120 Minutes After Drink Administration
timeFrame: Measured 15 minutes prior to capsule administration and 120 minutes after drink administration
measure: Change in Specific Drug Effects (Addiction Research Center Inventory) at 150 Minutes After Drink Administration
timeFrame: Measured 15 minutes prior to capsule administration and 150 minutes after drink administration
measure: Change in Specific Drug Effects (Addiction Research Center Inventory) at 180 Minutes After Drink Administration
timeFrame: Measured 15 minutes prior to capsule administration and 180 minutes after drink administration
measure: Change in Specific Drug Effects (Addiction Research Center Inventory) at 210 Minutes After Drink Administration
timeFrame: Measured 15 minutes prior to capsule administration and 210 minutes after drink administration
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Chicago
name: Harriet de Wit, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.