NCT02485158: TDS

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

Completed NA Results posted Last updated 6 October 2016

What this trial tests

NA trial testing THC in Healthy in 28 participants. Completed in 1 December 2013.

Timeline

1 July 2013

Primary endpoint
1 December 2013

1 December 2013

Quick facts

Lead sponsor	University of Chicago
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	basic science
Enrollment	28
Start date	1 July 2013
Primary completion	1 December 2013
Estimated completion	1 December 2013

Drugs / interventions tested

• THC — full drug profile →
• AMP — full drug profile →
• ALC — full drug profile →
• Placebo capsules — full drug profile →
• Placebo beverage — full drug profile →

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

University of Chicago

Who can join

Adults 21 to 35, any sex, with Healthy. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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 administratio
• 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.
• 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.
• 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
• 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
• 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

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Preliminary Investigation of Individual Differences in Subjective Responses to D-Amphetamine, Alcohol, and Delta-9-Tetrahydrocannabinol Using a Within-Subjects Randomized Trial.
   Wardle MC, Marcus BA, de Wit H. · · 2015 · cited 16× · PMID 26513587 · DOI 10.1371/journal.pone.0140501