Behavioral Economic Analysis of Demand for Marijuana
Primary Purpose
Marijuana Smoking
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Smoked marijuana cigarettes: High THC dose (6% THC)
Sponsored by
About this trial
This is an interventional basic science trial for Marijuana Smoking
Eligibility Criteria
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
Sites / Locations
- Brown University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
High THC dose (6% THC)
Arm Description
Smoked marijuana cigarettes (High THC dose [6% THC])
Outcomes
Primary Outcome Measures
Change in 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.
Secondary Outcome Measures
Change in Marijuana Craving Questionnaire (MCQ)
The Marijuana Craving Questionnaire will be used to collect data on craving for marijuana.
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 device tracks number of puffs, puff length, and inter-puff-interval.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03518567
Brief Title
Behavioral Economic Analysis of Demand for Marijuana
Official Title
Behavioral Economic Analysis of Demand for Marijuana
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
May 24, 2021 (Actual)
Study Completion Date
May 24, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marijuana Smoking
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
133 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High THC dose (6% THC)
Arm Type
Experimental
Arm Description
Smoked marijuana cigarettes (High THC dose [6% THC])
Intervention Type
Drug
Intervention Name(s)
Smoked marijuana cigarettes: High THC dose (6% THC)
Intervention Description
Smoked marijuana cigarettes (High THC dose [6% THC])
Primary Outcome Measure Information:
Title
Change in Marijuana Purchase Task (MPT)
Description
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.
Time Frame
MPT will be administered twice during the experimental session, up to 6 hours: at baseline and pre-smoking
Secondary Outcome Measure Information:
Title
Change in Marijuana Craving Questionnaire (MCQ)
Description
The Marijuana Craving Questionnaire will be used to collect data on craving for marijuana.
Time Frame
The MCQ will be administered pre- and post- marijuana smoking during the experimental session, up to 6 hours
Title
Marijuana Smoking Topography
Description
Indices of Marijuana Smoking Topography will be obtained during the experimental session. Participants will smoke marijuana through a smoking topography device. The device tracks number of puffs, puff length, and inter-puff-interval.
Time Frame
Marijuana smoking topography indices will be collected during the ad libitum marijuana smoking topography experimental session, up to 6 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Aston, PhD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
12. IPD Sharing Statement
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Behavioral Economic Analysis of Demand for Marijuana
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