Clinical trial NCT02592772: Manipulating Tobacco Constituents in Male Menthol Smokers
Official title: Manipulating Tobacco Constituents in Male Menthol Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Dependence
Keywords: menthol
nicotine
reduced nicotine
smoking
cigarette
cigarettes
men smoking
smoking research
nicotine dependence
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2015-10-30
Enrollment: 118
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gender differences and change in number of investigational tobacco product(s) smoked per day as assessed by the Timeline Follow-Back (TLFB)
timeFrame: Baseline, 6 weeks, and 12 weeks
Secondary outcomes:
measure: Gender differences and changes in craving as assessed by Minnesota Nicotine Withdrawal Scale (MNWS).
timeFrame: Baseline, 6 weeks, and 12 weeks
measure: Gender differences and changes in nicotine dependence as assessed by the Wisconsin Index of Smoking Dependence Motives (WISDM).
timeFrame: Baseline, 6 weeks, and 12 weeks
measure: Gender differences and changes in nicotine dependence as assessed by the Fagerstrom Test of Nicotine Dependence (FTND)
timeFrame: Baseline, 6 weeks, and 12 weeks
measure: Supertaster status as measured by genotyping for taster-receptor genes associated with taste behaviors.
timeFrame: Baseline
Other outcomes:
Locations:
city: Farmington
country: United States
facility: UCONN Health Center
state: Connecticut
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
Study officials:
affiliation: UConn Health
name: Cheryl Oncken, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Hartford HealthCare
name: Ellen Dornelas, PhD
role: PRINCIPAL_INVESTIGATOR
References: