Addiction and Behavior Related to Menthol Cigarette Substitutes

Smoking (Tobacco) Addiction Clinical Trial

— MENTHOL  

Official title:

Addiction and Behavior Related to Menthol Cigarette Substitutes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04844762
• Other study ID #: OSU-19145
• Secondary ID: 1R21DA046333-01A
• Status: Completed
• Phase: N/A
• Start date: December 16, 2019
• Est. completion date: August 9, 2021

Study information

• Verified date: February 2024
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 9, 2021
• Est. primary completion date: August 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Behavior, Addictive
• Smoking (Tobacco) Addiction

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	The Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (5)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	Brown University, National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), University of Vermont

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Puffing Topography: Puff Duration	Average puff duration for each participant, in seconds.	Phase 1, Four visits; 20 minute puffing session in total.
Primary	Puffing Topography: Inter-puff-interval	Inter-puff-interval, the average time between each puff for each participant, in seconds.	Phase 1, Four visits; 20 minute puffing session in total.
Primary	Puffing Topography: Puff Flow Rate	Puff flow rate, the average rate of air flow during each puff for each participant, in ml/second.	Phase 1, Four visits; 20 minute puffing session in total.
Primary	Puffing Topography: Total Puff Volume	The total volume of all puffs taken for each participant, in ml.	Phase 1, Four visits; 20 minute puffing session in total.
Primary	Drug Effects/Liking Questionnaire	An adapted version of the Drug Effects/Liking Questionnaire will assess the desire and liking of UBMC and all three study products, positive and negative effects (i.e., side effects), and perceived strength and effectiveness. Five visual analog scale items ranging from 0 ('not at all') to 100 ('extremely') assessed wanting to smoke the product again, liking the product, enjoying the product, finding the product pleasurable and satisfying.	Phases 1 and 3 - Up to 3 weeks
Primary	Modified Cigarette Evaluation Questionnaire (mCEQ)	The modified Cigarette Evaluation Questionnaire (mCEQ) will assess subjective responses to cigarettes (e.g., reward, satisfaction). The 11-item mCEQ includes five subscales: Smoking Satisfaction, Psychological Reward, Aversion, Enjoyment of Respiratory Tract Sensations, and Craving Reduction, with items rated from 1 (not at all) to 7 (extremely likely). Items are averaged to create each of the subscales also ranging from 1 to 7 with higher values indicating greater levels of smoking satisfaction, psychological reward, aversion, enjoyment of respiratory tract sensations, an craving reduction.	Phase 1 - Up to 2 weeks
Primary	Modified Cigarette Evaluation Questionnaire (mCEQ)	The modified Cigarette Evaluation Questionnaire (mCEQ) will assess subjective responses to cigarettes (e.g., reward, satisfaction). The 11-item mCEQ includes five subscales: Smoking Satisfaction, Psychological Reward, Aversion, Enjoyment of Respiratory Tract Sensations, and Craving Reduction, with items rated from 1 (not at all) to 7 (extremely likely). Items are averaged to create each of the subscales also ranging from 1 to 7 with higher values indicating greater levels of smoking satisfaction, psychological reward, aversion, enjoyment of respiratory tract sensations, an craving reduction.	Phase 3 - Approximately 3 hours
Primary	Cigarette Purchase Task	The Cigarette Purchase Task will ask participants how much they would be willing to pay (ranging from 0 cents to $1) to smoke each product. Given that the study products will look similar to cigarettes, we will retain the original language (e.g., 1 cigarette) in the purchase task. Willingness to spend more will indicate greater abuse liability. Pmax (the price associated with the maximal expenditure, i.e., the highest price before the curve changes from inelastic to elastic), and breakpoint (the last price in which consumption is greater than 0) are reported.	Phase 1 - Up to 2 weeks
Primary	Cigarette Purchase Task	The Cigarette Purchase Task will ask participants how much they would be willing to pay (ranging from 0 cents to $1) to smoke each product. Given that the study products will look similar to cigarettes, we will retain the original language (e.g., 1 cigarette) in the purchase task. Willingness to spend more will indicate greater abuse liability. Pmax (the price associated with the maximal expenditure, i.e., the highest price before the curve changes from inelastic to elastic), and breakpoint (the last price in which consumption is greater than 0) are reported.	Phase 3 - Approximately 3 hours
Primary	Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (Modified)	Smoking urges/craving will be measured using the Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form. This is a 10-item measure where participants rate smoking-related items (All I want right now is a cigarette) on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Similar to previous studies, we will collapse the items into two previously identified factors (Factor 1: strong desire and intention to smoke; Factor 2: anticipation of relief from withdrawal symptoms). Scores are calculated by summing the items and range from 5 to 35 with higher scores indicating greater craving to smoke.	Phase 1-3 - Up to 3 weeks
Primary	Minnesota Nicotine Withdrawal Scale	Nicotine withdrawal will be assessed using the empirically validated 15-item version of the Minnesota Nicotine Withdrawal Scale (MNWS). Items were rated on a 5-point scale from 0 (none) to 4 (severe). This measure assesses smoking craving, anger/irritability, anxiety, depressed mood, restlessness/difficulty concentrating, increased appetite, sleep problems, and somatic symptoms (nausea, constipation, sore throat, dizziness, coughing). MNWS is the sum of 7 items with scores ranging from 0 to 28 and MNWS Craving is a single item with scores ranging from 0 to 4, higher scores indicate a greater craving.	Phase 1-3 - Up to 3 weeks
Primary	Subjective Effects (EMA)	Subjective effects (EMA) of the Phase 2 substitute product will be derived from daily diary EMAs assessing product satisfaction and pleasure. Self-report measure with items rated from 1 (not at all) to 7 (extremely).	Phase 2 - 1 week
Primary	Cross Price Elasticity Task	A Cross-Price Task in Phases 1 and 3 will estimate substitutability of the study product for the UBMC. Participants will be asked how many study products and UBMCs they would consume when the price of the study product is fixed at $1 and the UBMC prices escalate. The data are then fit to an exponential equation that indicates whether the fixed-price product substitutes for the primary product, and the degree of substitution. Cross price elasticity (CPE) for each study product compared to UBMC > 0.2 indicates substitution, CPE < -0.2 indicates complementarity, and CPE between -0.2 and 0.2 indicate independence of the two products.	Phases 1 - Up to 2 weeks
Primary	Cross Price Elasticity Task	A Cross-Price Task in Phases 1 and 3 will estimate substitutability of the study product for the UBMC. Participants will be asked how many study products and UBMCs they would consume when the price of the study product is fixed at $1 and the UBMC prices escalate. The data are then fit to an exponential equation that indicates whether the fixed-price product substitutes for the primary product, and the degree of substitution. Cross price elasticity (CPE) for each study product compared to UBMC > 0.2 indicates substitution, CPE < -0.2 indicates complementarity, and CPE between -0.2 and 0.2 indicate independence of the two products.	Phase 3 - Approximately 3 hours
Primary	Progressive Ratio Task (UBMC vs. Study Product)	The PR task will simulate the effect that restricting menthol in cigarettes would have on increasing (or not) preference for other alternative menthol substitutes. Participants will complete a 90-minute concurrent choice task with different cost (effort) required to earn the reinforcement (2 puffs) from their UBMC and the study product (mFLC or mRYO). Puffs from the study product can be earned by clicking a computer mouse 10 times on a picture of the study product, but to earn two puffs of the UBMC, they will required to make escalating response requirements (computer mouse clicks) according to the following schedule: 10, 160, 320, 640, 1280, 2400, 3600, 4800, 6000, 7200, and 8400. A maximum of 10 reinforcers (20 puffs) per session will be allowed. Participants will be informed of the different sequence between products and instructed that the session are 3 hours in length no matter how much or how little they respond.	Phase 3 - Approximately 3 hours
Primary	Use Behavior (EMA)	Participants will receive on EMA delivered randomly during the day and an evening daily diary (around 30mins before bedtime). Random EMAs will assess: mood, affect, nicotine craving and withdrawal symptoms, stress, recency of smoking, alcohol use, current setting, and switching self-efficacy; daily diary EMAs will assess UBMC/study product smoked per day, product satisfaction and pleasure. Substitution assessed via use behavior during Phase 2 will be operationalized as the ratio of study product to UBMC used, with a ratio > 0 indicating any substitution and a ratio > 1 indicating substitution of study product for the UBMC at least 50% of the time.	Phase 2 - 1 week

External Links

•   Jamesline