N/A
N=103
Addiction and Behavior Related to Menthol Cigarette Substitutes
Smoking (Tobacco) Addiction
Bottom Line
View on ClinicalTrials.gov: NCT04844762 ↗Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Puffing Topography: Puff Duration — 1.99; 2.06; 2.66; 1.87 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Menthol cigarettes substitutes (Behavioral); Usual brand menthol cigarettes and substitutes (Behavioral); Menthol cigarettes substitutes and menthol cigarettes (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ohio State University Comprehensive Cancer Center
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Puffing Topography: Puff Duration |
1.99; 2.06; 2.66; 1.87 | — |
| PRIMARY Puffing Topography: Inter-puff-interval |
27.55; 27.54; 26.25; 27.79 | — |
| PRIMARY Puffing Topography: Puff Flow Rate |
23.75; 24.95; 16.97; 22.12 | — |
| PRIMARY Puffing Topography: Total Puff Volume |
462.92; 485.68; 434.66; 391.24 | — |
| PRIMARY Drug Effects/Liking Questionnaire |
91.49; 56.68; 26.72; 30.35; 96.02; 59.36 | — |
| PRIMARY Modified Cigarette Evaluation Questionnaire (mCEQ) |
3.89; 3.43; 3.52; 2.90; 2.26; 2.58 | — |
| PRIMARY Modified Cigarette Evaluation Questionnaire (mCEQ) |
3.89; 3.43; 3.52; 2.90; 2.26; 2.58 | — |
| PRIMARY Cigarette Purchase Task |
1.62; 1.11; 1.03; 3.36; 4.51; 2.69 | — |
| PRIMARY Cigarette Purchase Task |
1.62; 1.11; 1.03; 3.36; 4.51; 2.69 | — |
| PRIMARY Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (Modified) |
30.24; 29.63; 29.77; 29.77; 12.72; 11.60 | — |
| PRIMARY Minnesota Nicotine Withdrawal Scale |
4.59; 4.95; 5.17; 4.73; 2.34; 2.17 | — |
| PRIMARY Subjective Effects (EMA) |
3.80; 3.21; 3.67; 3.70; 2.93; 3.61 | — |
| PRIMARY Cross Price Elasticity Task |
0.282; 0.216; 0.281 | — |
| PRIMARY Cross Price Elasticity Task |
0.282; 0.216; 0.281 | — |
| PRIMARY Progressive Ratio Task (UBMC vs. Study Product) |
5.47; 4.70; 5.06 | — |
| PRIMARY Use Behavior (EMA) |
44; 8; 14; 8; 2; 4 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04844762). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.