Manipulating Tobacco Constituents in Male Menthol Smokers

Nicotine Dependence Clinical Trial

Official title:

Manipulating Tobacco Constituents in Male Menthol Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02592772
• Other study ID #: HHC-2015-0128
• Secondary ID: 3R01DA036486-02S
• Status: Completed
• Phase: N/A
• Start date: February 4, 2016
• Est. completion date: June 2019

Study information

• Verified date: April 2020
• Source: UConn Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: June 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

Intervention

Other:
• Reduced 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.
• Reduced 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.
• Conventional Nicotine Non-Menthol (CN)
Switch from own brand of cigarette to an investigational tobacco product which contains conventional nicotine yield.

Locations

Country	Name	City	State
United States	UCONN Health Center	Farmington	Connecticut
United States	Hartford Hospital	Hartford	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
UConn Health	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gender differences and change in number of investigational tobacco product(s) smoked per day as assessed by the Timeline Follow-Back (TLFB)	Data analyses will include subjects from this study matched to female subjects from the parent study.	Baseline, 6 weeks, and 12 weeks
Secondary	Gender differences and changes in craving as assessed by Minnesota Nicotine Withdrawal Scale (MNWS).		Baseline, 6 weeks, and 12 weeks
Secondary	Gender differences and changes in nicotine dependence as assessed by the Wisconsin Index of Smoking Dependence Motives (WISDM).		Baseline, 6 weeks, and 12 weeks
Secondary	Gender differences and changes in nicotine dependence as assessed by the Fagerstrom Test of Nicotine Dependence (FTND)		Baseline, 6 weeks, and 12 weeks
Secondary	Supertaster status as measured by genotyping for taster-receptor genes associated with taste behaviors.		Baseline