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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03518567
Other study ID # #1502001185
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 15, 2018
Est. completion date May 24, 2021

Study information

Verified date February 2024
Source Brown University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This laboratory study will employ a multi-session experimental design to examine the behavioral economic demand for marijuana, by studying effect of marijuana administration (High THC) on demand for marijuana, and marijuana smoking topography. The study will recruit 100 non-treatment seeking marijuana users who smoke marijuana at least twice weekly.


Description:

This laboratory study will employ a multi-session experimental design to examine craving for marijuana, the effect of marijuana administration (High THC) on behavioral economic demand for marijuana, and marijuana smoking topography. The study will recruit 100 non-treatment seeking marijuana users who smoke marijuana at least twice weekly. The relationship between hypothetical and actual demand for marijuana will be examined. We will also investigate relationship between demand for marijuana and indices of marijuana smoking topography. The study will recruit 100 non-treatment seeking marijuana users who smoke marijuana at least twice weekly to obtain a final sample of 85 with complete data (15% of attrition). Participants will be tested at a baseline session and during two experimental sessions (an ad libitum marijuana smoking session and a marijuana smoking topography session). This study will confirm the utility of the hypothetical marijuana purchase task as a reliable and valid tool for assessing behavioral economic marijuana demand.


Recruitment information / eligibility

Status Completed
Enrollment 133
Est. completion date May 24, 2021
Est. primary completion date May 24, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - marijuana use at least 8 times in the past month on average and at least monthly for the past 6 months - English-speaking - negative urine toxicology screen for drugs other than marijuana - non-treatment seeking - purchase of marijuana at least twice in the past 6 months to confirm familiarity with the construct to be measured Exclusion Criteria: - positive pregnancy test - nursing - inability to use contraception during the study - poor physical health - positive breath alcohol concentration - diagnosis of a current affective disorder, psychosis, and panic disorder - self-report of past serious adverse reaction to marijuana - current psychotropic drug use - smoking more than 20 tobacco cigarettes per day - inability to abstain from marijuana for 15 hours - body mass index outside 18.5-30 kg/m2 range

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Smoked marijuana cigarettes: High THC dose (6% THC)
Smoked marijuana cigarettes (High THC dose [6% THC])

Locations

Country Name City State
United States Brown University Providence Rhode Island

Sponsors (1)

Lead Sponsor Collaborator
Brown University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Validity of the Marijuana Purchase Task (MPT) The Marijuana Purchase Task will be used to collect data on marijuana demand. Participants indicate how much marijuana they would purchase at varying levels of price (e.g., free - $60). Indices of marijuana demand are derived from the task and used to determine the relative value of marijuana for each participant. Hits purchased on the MPT will correspond with actual number of hits purchased and smoked in the laboratory. Primary outcome is percentage of participants who purchased and smoked exactly what they said they would. Duration of the experimental session (i.e., 60 minutes)
Secondary Change in Marijuana Craving Questionnaire (MCQ) Subjective marijuana craving was assessed via a 10-item Marijuana Craving Questionnaire. Participants were asked to respond to items according to how they were thinking or feeling "right now," and MCQ items were rated on a 1 = "strongly disagree" to 7 = "strongly agree" scale, with higher scores indicating greater subjective marijuana craving, and summed to yield a total craving score. Total craving score was used in analyses. The MCQ will be administered pre- and post- marijuana smoking during the experimental session, up to 6 hours
Secondary Marijuana Smoking Topography Indices of Marijuana Smoking Topography will be obtained during the experimental session. Participants will smoke marijuana through a smoking topography device. The outcome measure is number of puffs. Marijuana smoking topography indices will be collected during the 1-hour ad libitum marijuana smoking topography experimental session.
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