NCT04844762

Addiction and Behavior Related to Menthol Cigarette Substitutes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

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, participants will complete 5 smoking sessions, each session smoking a different product examining each participants puff topography while sampling the product, the products' ability to suppress nicotine craving/withdrawal, and the product's demand indices. Products will include participants usual brand menthol cigarette (UBMC) as well as 3 commercially-available alternatives, including an mFLC, a pre-assembled mRYO product (menthol tobacco and non-menthol tube), and an nmC. All sessions will occur following 12 hours of nicotine abstinence and be separated by 48 hours. In Phase 2, participants will select their preferred study product from Phase 1 and be instructed to completely substitute the product for their UBMC for one week. Participants will complete ecological momentary assessments (EMA) during this period to more accurately assess degree of substitution and perceived effects in real time. In Phase 3, participants will complete a final in-lab visit to assess the substitutability of their preferred product, under simulated ban conditions using a progressive ratio task. In all phases, multiple domains of abuse liability will be assessed, including product administration (in-lab puff topography and EMA self-report measures), product liking and craving and withdrawal suppression (in-lab and EMA self-report), and a hypothetical purchase task to simulate demand.

Conditions

• Smoking (Tobacco) Addiction

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-12-16
• Primary completion: 2021-08-09
• Completion: 2021-08-09
• First posted: 2021-04-14
• Last updated: 2024-02-09
• Results posted: 2024-02-09

Locations

1 site across 1 country: United States