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Clinical Trials/NCT03546790
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
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

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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