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Laboratory Smoking of Marijuana "Blunts"

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03546790
Recruitment Status : Completed
First Posted : June 6, 2018
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Battelle Memorial Institute

Tracking Information
First Submitted Date  ICMJE May 23, 2018
First Posted Date  ICMJE June 6, 2018
Last Update Posted Date October 2, 2019
Actual Study Start Date  ICMJE April 10, 2019
Actual Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2018)
Puff topography [ Time Frame: During marijuana blunt smoking ]
Total inhalation volume
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2018)
  • Carbon monoxide [ Time Frame: Immediately after marijuana blunt smoking ]
    Exhaled breath carbon monoxide (ppm)
  • Subjective drug effects [ Time Frame: Immediately after marijuana blunt smoking ]
    Ratings of "good" and "high"
  • Measures of demand [ Time Frame: Immediately after marijuana blunt smoking ]
    Number of units an individual would purchase at varying price points
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Laboratory Smoking of Marijuana "Blunts"
Official Title  ICMJE Laboratory Smoking of Marijuana "Blunts"
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Cannabis
Intervention  ICMJE Drug: Marijuana
Marijuana smoked via blunts with different cigar wrappers
Study Arms  ICMJE
  • Experimental: Flavor 1
    Grape flavored tobacco cigar wrapper
    Intervention: Drug: Marijuana
  • Experimental: Flavor 2
    Chocolate flavored tobacco cigar wrapper
    Intervention: Drug: Marijuana
  • Experimental: Flavor 3
    Tobacco flavored tobacco cigar wrapper
    Intervention: Drug: Marijuana
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 30, 2019)
8
Original Estimated Enrollment  ICMJE
 (submitted: June 4, 2018)
20
Actual Study Completion Date  ICMJE September 30, 2019
Actual Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03546790
Other Study ID Numbers  ICMJE BMI-104112
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Battelle Memorial Institute
Study Sponsor  ICMJE Battelle Memorial Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wallace B Pickworth, PhD Battelle Memorial Institute
PRS Account Battelle Memorial Institute
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP