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Laboratory Smoking of Marijuana "Blunts"

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ClinicalTrials.gov Identifier: NCT03546790
Recruitment Status : Recruiting
First Posted : June 5, 2018
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cannabis Drug: Marijuana Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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 : April 10, 2019
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

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




Primary Outcome Measures :
  1. Puff topography [ Time Frame: During marijuana blunt smoking ]
    Total inhalation volume


Secondary Outcome Measures :
  1. Carbon monoxide [ Time Frame: Immediately after marijuana blunt smoking ]
    Exhaled breath carbon monoxide (ppm)

  2. Subjective drug effects [ Time Frame: Immediately after marijuana blunt smoking ]
    Ratings of "good" and "high"

  3. Measures of demand [ Time Frame: Immediately after marijuana blunt smoking ]
    Number of units an individual would purchase at varying price points



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03546790


Contacts
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Contact: Carson Smith, MPH, MPA +1 (410) 372-2705 smithc@battelle.org

Locations
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United States, Maryland
Battelle Memorial Institute Recruiting
Baltimore, Maryland, United States, 21209
Contact: Carson Smith, MPH    410-372-2705    smithc@battelle.org   
Principal Investigator: Wallace B Pickworth, PhD         
Sponsors and Collaborators
Battelle Memorial Institute
Investigators
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Principal Investigator: Wallace B Pickworth, PhD Battelle Memorial Institute

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Responsible Party: Battelle Memorial Institute
ClinicalTrials.gov Identifier: NCT03546790     History of Changes
Other Study ID Numbers: BMI-104112
First Posted: June 5, 2018    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders