Laboratory Smoking of Marijuana "Blunts"

Cannabis Clinical Trial

Official title:

Laboratory Smoking of Marijuana "Blunts"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03546790
• Other study ID #: BMI-104112
• Status: Completed
• Phase: Phase 1
• Start date: April 10, 2019
• Est. completion date: September 30, 2019

Study information

• Verified date: September 2019
• Source: Battelle Memorial Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Cannabis
• Marijuana Abuse

Intervention

Drug:
• Marijuana
Marijuana smoked via blunts with different cigar wrappers

Locations

Country	Name	City	State
United States	Battelle Memorial Institute	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Battelle Memorial Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Puff topography	Total inhalation volume	During marijuana blunt smoking
Secondary	Carbon monoxide	Exhaled breath carbon monoxide (ppm)	Immediately after marijuana blunt smoking
Secondary	Subjective drug effects	Ratings of "good" and "high"	Immediately after marijuana blunt smoking
Secondary	Measures of demand	Number of units an individual would purchase at varying price points	Immediately after marijuana blunt smoking