Laboratory Smoking of Marijuana "Blunts"
1 other identifier
interventional
8
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Apr 2019
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2018
CompletedFirst Posted
Study publicly available on registry
June 6, 2018
CompletedStudy Start
First participant enrolled
April 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2019
CompletedOctober 2, 2019
September 1, 2019
6 months
May 23, 2018
September 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Puff topography
Total inhalation volume
During marijuana blunt smoking
Secondary Outcomes (3)
Carbon monoxide
Immediately after marijuana blunt smoking
Subjective drug effects
Immediately after marijuana blunt smoking
Measures of demand
Immediately after marijuana blunt smoking
Study Arms (3)
Flavor 1
EXPERIMENTALGrape flavored tobacco cigar wrapper
Flavor 2
EXPERIMENTALChocolate flavored tobacco cigar wrapper
Flavor 3
EXPERIMENTALTobacco flavored tobacco cigar wrapper
Interventions
Eligibility Criteria
You may qualify if:
- Currently living in Baltimore City or Baltimore County, MD;
- Able to read, understand, and sign informed consent;
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Battelle Memorial Institute
Baltimore, Maryland, 21209, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wallace B Pickworth, PhD
Battelle Memorial Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2018
First Posted
June 6, 2018
Study Start
April 10, 2019
Primary Completion
September 30, 2019
Study Completion
September 30, 2019
Last Updated
October 2, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share