Clinical trial NCT04844762: Addiction and Behavior Related to Menthol Cigarette Substitutes
Official title: Addiction and Behavior Related to Menthol Cigarette Substitutes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking (Tobacco) Addiction
Keywords: Menthol cigarettes
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: University of Vermont
name: Brown University
name: National Institutes of Health (NIH)
name: National Institute on Drug Abuse (NIDA)
First posted: 2021-04-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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 (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.

Eligibility criteria: 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

Primary outcomes:
measure: Puffing Topography: Puff Duration
timeFrame: Phase 1, Four visits; 20 minute puffing session in total.
measure: Puffing Topography: Inter-puff-interval
timeFrame: Phase 1, Four visits; 20 minute puffing session in total.
measure: Puffing Topography: Puff Flow Rate
timeFrame: Phase 1, Four visits; 20 minute puffing session in total.
measure: Puffing Topography: Total Puff Volume
timeFrame: Phase 1, Four visits; 20 minute puffing session in total.
measure: Drug Effects/Liking Questionnaire
timeFrame: Phases 1 and 3 - Up to 3 weeks
measure: Modified Cigarette Evaluation Questionnaire (mCEQ)
timeFrame: Phase 1 - Up to 2 weeks
measure: Modified Cigarette Evaluation Questionnaire (mCEQ)
timeFrame: Phase 3 - Approximately 3 hours
measure: Cigarette Purchase Task
timeFrame: Phase 1 - Up to 2 weeks
measure: Cigarette Purchase Task
timeFrame: Phase 3 - Approximately 3 hours
measure: Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (Modified)
timeFrame: Phase 1-3 - Up to 3 weeks
measure: Minnesota Nicotine Withdrawal Scale
timeFrame: Phase 1-3 - Up to 3 weeks
measure: Subjective Effects (EMA)
timeFrame: Phase 2 - 1 week
measure: Cross Price Elasticity Task
timeFrame: Phases 1 - Up to 2 weeks
measure: Cross Price Elasticity Task
timeFrame: Phase 3 - Approximately 3 hours
measure: Progressive Ratio Task (UBMC vs. Study Product)
timeFrame: Phase 3 - Approximately 3 hours
measure: Use Behavior (EMA)
timeFrame: Phase 2 - 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Theodore Wagener, PhD
role: PRINCIPAL_INVESTIGATOR
References: