Status:
COMPLETED
Addiction and Behavior Related to Menthol Cigarette Substitutes
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Collaborating Sponsors:
University of Vermont
Brown University
Conditions:
Smoking (Tobacco) Addiction
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
The goal of the proposed study is to examine the abuse liability and substitutability of plausible menthol cigarette alternatives currently on the market, including menthol filtered little cigars (mFL...
Detailed Description
Using an in-laboratory and ad libitum outpatient mixed design, 80 current menthol cigarette smokers will complete a three phase, 3 week study: in Phase 1, utilizing a randomized crossover design, part...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- current menthol cigarette smoker (\>90% menthol cigarette use; ≥5 cigarettes per day) for at least the past 6 months.
- between 18-24 (young adult) or 25-50 years old (aged 25+)
- willing to provide informed consent and abstain from all tobacco and nicotine use for at least 12 hours prior to the five lab sessions
- willing to complete one week of EMA
- read and speak English.
- Exclusion criteria:
- self-reported diagnosis of lung disease including asthma, cystic fibrosis, or chronic obstructive pulmonary disease
- unstable or significant psychiatric conditions (past and stable conditions will be allowed)
- history of cardiac event or distress within the past 3 months
- currently pregnant, planning to become pregnant, or breastfeeding (will be verified with urine pregnancy test)
- use of other tobacco products (e.g., e-cig, cigar, etc.) \>5 days in the past month
- current marijuana use \>5 times per month
- any use of other illicit drugs during the last 30 days (verified by urinalysis at initial visit)
- currently engaging in a smoking cessation attempt
- currently using one of the alternative menthol study products
Exclusion
Key Trial Info
Start Date :
December 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 9 2021
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04844762
Start Date
December 16 2019
End Date
August 9 2021
Last Update
February 9 2024
Active Locations (1)
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1
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43214