Addiction and Behavior Related to Menthol Cigarette Substitutes

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-16

Study Completion Date

2021-08-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cooling Agent Pilot Among Adult Menthol Smokers

NCT06477601

Tobacco Dependence

COMPLETED NA

Effective Ads for Quitting Smoking

NCT06485479

Smoking Behaviors

COMPLETED NA

Smoking Topography and Harm Exposure in Menthol Cigarettes

NCT01329263

Cigarette Smoking Toxicity

COMPLETED NA

Evaluating the Impact of Synthetic Cooling Agents in Combustible Cigarettes on Smoking Perceptions and Use

NCT06230159

Cigarette Smoking-Related Carcinoma

COMPLETED NA

Manipulating Tobacco Constituents in Male Menthol Smokers

NCT02592772

Nicotine Dependence

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Smoking (Tobacco) Addiction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

usual brand menthol cigarette (UBMC)

Study participant's usual brand menthol cigarette

Group Type ACTIVE_COMPARATOR

Menthol cigarettes substitutes

Intervention Type BEHAVIORAL

In Phase 1, participants will complete 4 smoking sessions using a different product each session to examine each product's abuse liability.

Menthol cigarettes substitutes and menthol cigarettes

Intervention Type BEHAVIORAL

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.

menthol roll-your-own cigarette (mRYO)

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

Group Type ACTIVE_COMPARATOR

Menthol cigarettes substitutes

Intervention Type BEHAVIORAL

In Phase 1, participants will complete 4 smoking sessions using a different product each session to examine each product's abuse liability.

Usual brand menthol cigarettes and substitutes

Intervention Type BEHAVIORAL

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.

Menthol cigarettes substitutes and menthol cigarettes

Intervention Type BEHAVIORAL

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.

menthol filtered little cigar (mFLC)

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

Group Type ACTIVE_COMPARATOR

Menthol cigarettes substitutes

Intervention Type BEHAVIORAL

In Phase 1, participants will complete 4 smoking sessions using a different product each session to examine each product's abuse liability.

Usual brand menthol cigarettes and substitutes

Intervention Type BEHAVIORAL

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.

Menthol cigarettes substitutes and menthol cigarettes

Intervention Type BEHAVIORAL

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.

non-menthol cigarette (nmC)

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

Group Type ACTIVE_COMPARATOR

Menthol cigarettes substitutes

Intervention Type BEHAVIORAL

In Phase 1, participants will complete 4 smoking sessions using a different product each session to examine each product's abuse liability.

Usual brand menthol cigarettes and substitutes

Intervention Type BEHAVIORAL

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.

Menthol cigarettes substitutes and menthol cigarettes

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes