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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03471585
Other study ID # IRB16-1132
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date February 15, 2017
Est. completion date October 4, 2017

Study information

Verified date March 2018
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main purpose of this study was to examine the effects of THC on the retrieval of emotional and neutral memories in healthy young adults. Secondary experiments included the effects of THC on the encoding of object and scene stimuli and a novel working memory task.


Description:

Here, the investigators aimed to investigate the effects of THC (15 mg) on the retrieval of negative, neutral, and positive memories. The study used a placebo-controlled, within-subjects, crossover design with 24 participants. In each experimental arm, participants attend a session to encode stimuli, a second session 48 hours later in which their memories are tested for the stimuli from the first session followed by the encoding of object-scene stimuli and a working memory test, and a third session 48 hours later in which memory for the object-scene stimuli is tested. In the second session, two hours prior to memory testing, THC or placebo is administered. On the first and second sessions subjects complete mood questionnaires.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date October 4, 2017
Est. primary completion date October 4, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- 4-100 lifetime cannabis occasions

Exclusion Criteria:

- Current Axis I DSM-IV disorder, including substance dependence, current use of >5 cigarettes per day, history of psychosis or mania, less than a high school education, lack of English fluency, a body mass index outside 19-33 kg/m2, high blood pressure (>140/90), abnormal electrocardiogram, daily use of any medication other than birth control, pregnancy, or lactating.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
THC
A capsule that contains 15 mg of THC as well as dextrose filler administered 2 hours prior to memory testing.
Placebo oral capsule
A capsule that contains only dextrose filler administered 2 hours prior to memory testing.

Locations

Country Name City State
United States University of Chicago Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Emotional Memory Hit and false alarm rates for negative, neutral, and positive picture stimuli Two hours after placebo/THC administration.
Primary DRM Memory Hit and false alarm rates for the DRM task Two and a half hours after placebo/THC administration.
Primary Object Memory Hit and false alarm rates for object stimuli on the same or different encoding scenes 48 hours after placebo/THC administration.
Secondary Addiction Research Centre Inventory Marijuana Scale The Addiction Research Centre Inventory (ARCI; Martin, Sloan, Sapira, & Jasinski, 1971) measures drug-specific effects on a 56-item true-false questionnaire. For this study, the investigators report the composite score of 12 questions that make up the marijuana scale (Chait, Fischman, & Schuster, 1985). Assessed just prior to placebo/THC administration and then 30 minutes, 60 minutes, 90 minutes, and 115 minutes after placebo/THC administration.
Secondary Visual Analog Scales The Visual Analog Scales (VAS; Folstein & Luria, 1973) is composed of thirteen adjectives used to assess individual dimensions of subjective mood - anxious, stimulated, sedated, elated, insightful, sociable, confident, lonely, playful, dizzy, loving, friendly, and restless, rated on a sliding scale from 'not at all' to 'extremely.' Assessed just prior to placebo/THC administration and then 30 minutes, 60 minutes, 90 minutes, and 115 minutes after placebo/THC administration.
Secondary Drug Effects Questionnaire The Drug Effects Questionnaire (DEQ; Morean et al., 2013) is composed of five questions concerning current drug effects - how much participants feel a drug effect, like the effect, dislike the effect, feel high, and want more of the drug, rated on a sliding scale from 'not at all/neutral' to 'very much.' Assessed just prior to placebo/THC administration and then 30 minutes, 60 minutes, 90 minutes, and 115 minutes after placebo/THC administration.
Secondary Physiological Measure 1 Heart rate Assessed just prior to placebo/THC administration and then 30 minutes, 60 minutes, 90 minutes, and 115 minutes after placebo/THC administration.
Secondary Physiological Measure 2 Blood pressure Assessed just prior to placebo/THC administration and then 30 minutes, 60 minutes, 90 minutes, and 115 minutes after placebo/THC administration.
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