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Laboratory Smoking of Marijuana "Blunts"

Sponsor
Battelle Memorial Institute (Other)
Overall Status
Completed
CT.gov ID
NCT03546790
Collaborator
(none)
8
Enrollment
1
Location
3
Arms
5.7
Actual Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Laboratory Smoking of Marijuana "Blunts"
Actual Study Start Date :
Apr 10, 2019
Actual Primary Completion Date :
Sep 30, 2019
Actual Study Completion Date :
Sep 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Flavor 1

Grape flavored tobacco cigar wrapper

Drug: Marijuana
Marijuana smoked via blunts with different cigar wrappers
Experimental: Flavor 2

Chocolate flavored tobacco cigar wrapper

Drug: Marijuana
Marijuana smoked via blunts with different cigar wrappers
Experimental: Flavor 3

Tobacco flavored tobacco cigar wrapper

Drug: Marijuana
Marijuana smoked via blunts with different cigar wrappers

Outcome Measures

Primary Outcome Measures

  1. Puff topography [During marijuana blunt smoking]

    Total inhalation volume

Secondary Outcome Measures

  1. Carbon monoxide [Immediately after marijuana blunt smoking]

    Exhaled breath carbon monoxide (ppm)

  2. Subjective drug effects [Immediately after marijuana blunt smoking]

    Ratings of "good" and "high"

  3. Measures of demand [Immediately after marijuana blunt smoking]

    Number of units an individual would purchase at varying price points

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Battelle Memorial Institute Baltimore Maryland United States 21209

Sponsors and Collaborators

  • Battelle Memorial Institute

Investigators

  • Principal Investigator: Wallace B Pickworth, PhD, Battelle Memorial Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Battelle Memorial Institute
ClinicalTrials.gov Identifier:
NCT03546790
Other Study ID Numbers:
  • BMI-104112
First Posted:
Jun 6, 2018
Last Update Posted:
Oct 2, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Battelle Memorial Institute
Cannabis
Additional relevant MeSH terms:
Marijuana Abuse

Study Results

No Results Posted as of Oct 2, 2019