Addiction and Behavior Related to Menthol Cigarette Substitutes (MENTHOL)

The Ohio State University

Status: Completed

Conditions: Smoking (Tobacco) Addiction

Treatments: Behavioral: Menthol cigarettes substitutes; Behavioral: Usual brand menthol cigarettes and substitutes; Behavioral: Menthol cigarettes substitutes and menthol cigarettes

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04844762

OSU-19145

1R21DA046333-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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120 participants in 4 patient groups

usual brand menthol cigarette (UBMC)

Active Comparator group

Description:

Study participant's usual brand menthol cigarette

Treatment:

Behavioral: Menthol cigarettes substitutes and menthol cigarettes

Behavioral: Menthol cigarettes substitutes

menthol roll-your-own cigarette (mRYO)

Active Comparator group

Description:

Mentholated pipe tobacco in a roll-your-own cigarette tube

Treatment:

Behavioral: Usual brand menthol cigarettes and substitutes

Behavioral: Menthol cigarettes substitutes and menthol cigarettes

Behavioral: Menthol cigarettes substitutes

menthol filtered little cigar (mFLC)

Active Comparator group

Description:

The menthol filtered cigar will be Cheyenne (Cheyennecigars.com) Seneca (senecacigars.com)

Treatment:

Behavioral: Usual brand menthol cigarettes and substitutes

Behavioral: Menthol cigarettes substitutes and menthol cigarettes

Behavioral: Menthol cigarettes substitutes

non-menthol cigarette (nmC)

Active Comparator group

Description:

The non-menthol cigarette will be Newport non-menthol cigarettes.

Treatment:

Behavioral: Usual brand menthol cigarettes and substitutes

Behavioral: Menthol cigarettes substitutes and menthol cigarettes

Behavioral: Menthol cigarettes substitutes