NCT03546790CompletedPhase 1
Laboratory Smoking of Marijuana "Blunts"
Battelle Memorial Institute1 site in 1 country8 target enrollmentStarted: April 10, 2019Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Battelle Memorial Institute
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Puff topography
Study Overview
Brief Summary
This is a double-blind within-subjects clinical laboratory study comparing the product appeal and abuse liability-related subjective effects of different flavored cigar wrappers for marijuana blunts.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Currently living in Baltimore City or Baltimore County, MD;
- •Able to read, understand, and sign informed consent;
- •18-55 years old;
- •Currently smokes marijuana blunts;
- •Designation of Medically Healthy for Research by the Study Physician; and
- •Willing to abstain from illicit drug use other than marijuana for the duration of the study.
Exclusion Criteria
- •BAC > 0.020% as measured by alcohol breathalyzer;
- •Meets DSM-5 criteria for severe current or lifetime Cannabis Use Disorder;
- •Meets DSM-5 criteria for any current Axis I disorder, other than current mild or moderate Cannabis Use Disorder;
- •Self-reported current desire to stop marijuana use;
- •Self-reported current asthma, chronic obstructive pulmonary disease, hypertension, cardiovascular disease or any other medical illness that precludes participation;
- •Has difficulties with blood draws or poor venous access;
- •History of blood donation in the past 30 days or receiving blood products within the past 2 months prior to any experimental visit;
- •Among females, current pregnancy or lactation or attempting to get pregnant, or at risk of becoming pregnant;
- •Acute illness which will require participant to be rescheduled
Arms & Interventions
Flavor 1
Experimental
Grape flavored tobacco cigar wrapper
Intervention: Marijuana (Drug)
Flavor 2
Experimental
Chocolate flavored tobacco cigar wrapper
Intervention: Marijuana (Drug)
Flavor 3
Experimental
Tobacco flavored tobacco cigar wrapper
Intervention: Marijuana (Drug)
Outcomes
Primary Outcomes
Puff topography
Time Frame: During marijuana blunt smoking
Total inhalation volume
Secondary Outcomes
- Carbon monoxide(Immediately after marijuana blunt smoking)
- Subjective drug effects(Immediately after marijuana blunt smoking)
- Measures of demand(Immediately after marijuana blunt smoking)
Investigators
Study Sites (1)
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