Nicotine Dependence
Conditions
Keywords
menthol, nicotine, reduced nicotine, smoking, cigarette, cigarettes, men smoking, smoking research, nicotine dependence
Brief summary
This study examines the potential effect of reducing nicotine content or menthol or both in men. It will also examine whether there are gender differences in manipulating tobacco flavors and nicotine concentrations in cigarettes on smoking behavior.
Detailed description
The FDA has the regulatory authority to reduce, but not eliminate, nicotine from cigarettes. The Tobacco Products Scientific Advisory Committee has noted, among other things, that removal of menthol cigarettes from the marketplace would benefit the public health. A parent study (NCT02048852) examines the potential impact of these two regulatory actions alone and in combination in female menthol smokers. This supplemental study will recruit an additional group of male menthol smokers, which will examine whether there are gender differences in manipulating flavors and nicotine concentrations in cigarettes on smoking behavior. The approach to add the opposite sex allows findings of sex/gender to be incorporated in the design and development of new technologies (i.e., modified cigarettes). Emerging research shows that women may be more responsive to the non-nicotine sensory aspects of smoking such as menthol flavor, whereas men may smoke primarily for nicotine intake. Consequently, this study expects to observe gender differences in response to manipulating flavors and nicotine content in cigarettes.
Interventions
OTHERReduced Nicotine Non-Menthol (RNC)
Switch from own brand of cigarette to an investigational tobacco product with a reduced nicotine content of 0.07mg nicotine yield without menthol.
OTHERReduced Nicotine Menthol (RNC-Men)
Switch from own brand of cigarette to an investigational tobacco product with a reduced nicotine content of 0.07mg nicotine yield with menthol.
OTHERConventional Nicotine Non-Menthol (CN)
Switch from own brand of cigarette to an investigational tobacco product which contains conventional nicotine yield.
Sponsors
National Institute on Drug Abuse (NIDA)
UConn Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. smoking at least 5 menthol cigarettes daily for the last year; 2. able to speak, read and understand English; 3. male age 18 -45 years of age; 4. stable residence; 5. not intending to quit smoking within the next 6 weeks.
Exclusion criteria
1. unstable psychiatric disorder (Psychiatric symptoms reported that cause current significant impairment in functioning or judgment such that the person's ability to come consistently for study appointments or render a decision regarding informed consent is in question.); 2. substance use which exceeds any of the following: marijuana use 3x/week, consuming 21 drinks/week or illicit drug use 1x/week; 3. history of cardiovascular disease; 4. current blood clot in arms or legs; 5. blood pressure \>160/100; 6. unstable medical problems which may include but are not limited to immune system disorders, severe respiratory diseases, kidney or liver diseases, thyroid problems, substance abuse or dependence that would limit patients ability to follow experimental protocol 7. Serious quit attempts in the last 3 months; 8. regular use (e.g., greater than weekly) of tobacco products other than cigarettes; 9. currently using nicotine replacement or other tobacco cessation products
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gender differences and change in number of investigational tobacco product(s) smoked per day as assessed by the Timeline Follow-Back (TLFB) | Baseline, 6 weeks, and 12 weeks | Data analyses will include subjects from this study matched to female subjects from the parent study. |
Secondary
| Measure | Time frame |
|---|---|
| Gender differences and changes in craving as assessed by Minnesota Nicotine Withdrawal Scale (MNWS). | Baseline, 6 weeks, and 12 weeks |
| Gender differences and changes in nicotine dependence as assessed by the Wisconsin Index of Smoking Dependence Motives (WISDM). | Baseline, 6 weeks, and 12 weeks |
| Gender differences and changes in nicotine dependence as assessed by the Fagerstrom Test of Nicotine Dependence (FTND) | Baseline, 6 weeks, and 12 weeks |
| Supertaster status as measured by genotyping for taster-receptor genes associated with taste behaviors. | Baseline |
Countries
United States
Outcome results
None listed