Laboratory Smoking of Marijuana "Blunts"

Phase 1

Completed

• Conditions: Cannabis
• Interventions: Drug: Marijuana

• Registration Number: NCT03546790
• Lead Sponsor: Battelle Memorial Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-23
• Study First Submitted QC: 2018-06-04
• Study First Posted: 2018-06-06
• Study Start: 2019-04-10
• Status Verified: 2019-09
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Last Update Submitted: 2019-09-30
• Last Update Posted: 2019-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Flavor 3	Marijuana	Tobacco flavored tobacco cigar wrapper
Flavor 1	Marijuana	Grape flavored tobacco cigar wrapper
Flavor 2	Marijuana	Chocolate flavored tobacco cigar wrapper

Primary Outcome Measures

Name	Time	Method
Puff topography	During marijuana blunt smoking	Total inhalation volume

Secondary Outcome Measures

Name	Time	Method
Carbon monoxide	Immediately after marijuana blunt smoking	Exhaled breath carbon monoxide (ppm)
Subjective drug effects	Immediately after marijuana blunt smoking	Ratings of "good" and "high"
Measures of demand	Immediately after marijuana blunt smoking	Number of units an individual would purchase at varying price points

Trial Locations

Locations (1)

Battelle Memorial Institute; 🇺🇸 Baltimore, Maryland, United States