Addiction and Behavior Related to Menthol Cigarette Substitutes
NCT04844762 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2024-02-09
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 (mFLC), menthol roll-your-own (mRYO) pipe tobacco and cigarette tubes, and non-menthol cigarettes (nmC). In addition, the study will elucidate real-time mechanisms including product characteristics and perceived effects associated with greater substitution.
Conditions
- Smoking (Tobacco) Addiction
Interventions
- BEHAVIORAL
-
Menthol cigarettes substitutes
In Phase 1, participants will complete 4 smoking sessions using a different product each session to examine each product's abuse liability.
- BEHAVIORAL
-
Usual brand menthol cigarettes and substitutes
In Phase 2, to assess uptake, changes in subjective effects, and use over time, participants will select their preferred study product from Phase 1 and be instructed to completely substitute the product for their usual brand menthol cigarette for one week.
- BEHAVIORAL
-
Menthol cigarettes substitutes and menthol cigarettes
In Phase 3, participants will complete a final in-lab visit to assess the substitutability of their preferred product from Phases 1 and 2, under simulated ban conditions using a progressive ratio task.
Sponsors & Collaborators
-
University of Vermont
collaborator OTHER -
Brown University
collaborator OTHER -
National Institutes of Health (NIH)
collaborator NIH -
National Institute on Drug Abuse (NIDA)
collaborator NIH -
Ohio State University Comprehensive Cancer Center
lead OTHER
Principal Investigators
-
Theodore Wagener, PhD · Ohio State University Comprehensive Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- SINGLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-12-16
- Primary Completion
- 2021-08-09
- Completion
- 2021-08-09
Countries
- United States
Study Locations
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