Tobacco Use Clinical Trial
— MJCIGOfficial title:
A Laboratory Model of Increasing THC Potency on Cigarette Smoking
Verified date | September 2019 |
Source | Battelle Memorial Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of the proposed research is to investigate how smoking increasing potency of THC (i.e., the psychoactive ingredient in marijuana) changes tobacco cigarette smoking behavior, urges, subjective effects, and abuse liability. This study will be a within-subjects, placebo-controlled study in our clinical laboratory of the effect of active vs. placebo marijuana on cigarette puff topography, exhaled carbon monoxide, urge, subjective effects, and abuse liability among 7 adults who smoke both marijuana and tobacco cigarettes.
Status | Completed |
Enrollment | 9 |
Est. completion date | September 30, 2019 |
Est. primary completion date | April 24, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Current US resident; 2. Age = 18 years; 3. Self-reported smoking of marijuana no more than three days per week within the past year; 4. Self-report past-month smoking of marijuana; 5. Self-report daily smoking of at least five cigarettes per day within the past year; 6. Cotinine = 100 ng/mL at the in-person screening visit; and 7. Able to read, understand, and sign informed consent. Exclusion Criteria: 1. Meets Diagnostic and Statistical Manual-5 (DSM-5) criteria for current (i.e., past year) or past (i.e., lifetime) cannabis use disorder; 2. Meets DSM-5 criteria for any current Axis I disorder, other than tobacco use disorder; 3. Self-reported current desire to stop marijuana or tobacco use, defined as 7 or greater on an 11-rung (scaled of 1-10) Contemplation Ladder for each; 4. Self-reported asthma or chronic obstructive pulmonary disease; and 5. Among females, current pregnancy or lactation. |
Country | Name | City | State |
---|---|---|---|
United States | Battelle Memorial Institute | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Battelle Memorial Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Puff topography of tobacco cigarette smoked | Mean total puff volume | 30 minutes post-marijuana smoking | |
Secondary | Boost in exhaled breath carbon monoxide after smoking tobacco cigarette | Pre- to post-tobacco cigarette smoking difference in exhaled breath carbon monoxide | 30 minutes post-marijuana smoking | |
Secondary | Self-reported urge to smoke tobacco cigarette | Pre- to post-tobacco cigarette smoking difference in scores on the Questionnaire of Smoking Urge | 30 minutes post marijuana smoking | |
Secondary | Self-reported subjective effects related to tobacco cigarette smoking | Pre- to post-tobacco cigarette smoking difference in the Nicotine-Drug Effects Questionnaire | 30 minutes post marijuana smoking |
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