Manipulating Tobacco Constituents in Male Menthol Smokers

NCT ID: NCT02592772

Last Updated: 2020-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-04
• Study Completion Date: 2019-06-30

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.

Conditions

Nicotine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Reduced Nicotine Non-Menthol (RNC)

Study participants will be randomized from their own brand of menthol cigarettes to the reduced nicotine non menthol cigarettes (RNC: NRC 200; 0.07 mg nicotine yield cigarettes without menthol) during the 6 week experimental phase.

Group Type: EXPERIMENTAL

Reduced Nicotine Non-Menthol (RNC)

Intervention Type: OTHER

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)

Study participants will be randomized from their own brand of menthol cigarettes to the reduced nicotine menthol cigarettes (RNC-Men: NRC 201; 0.07 mg reduced nicotine content menthol cigarettes) during the 6 week experimental phase.

Group Type: EXPERIMENTAL

Reduced Nicotine Menthol (RNC-Men)

Intervention Type: OTHER

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)

Study participants will be randomized from their own brand of menthol cigarettes to the regular/conventional nicotine non menthol cigarettes (CN: NRC 600; 0.8 mg nicotine content) during the 6 week experimental phase.

Group Type: EXPERIMENTAL

Conventional Nicotine Non-Menthol (CN)

Intervention Type: OTHER

Switch from own brand of cigarette to an investigational tobacco product which contains conventional nicotine yield.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Conventional Nicotine Non-Menthol (CN)

Switch from own brand of cigarette to an investigational tobacco product which contains conventional nicotine yield.

Intervention Type: OTHER

Other Intervention Names

SPECTRUM Research Cigarette - NRC 200; SPECTRUM Research Cigarette - NRC 201; SPECTRUM Research Cigarette - NRC 600

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

UConn Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cheryl Oncken, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

UConn Health

Ellen Dornelas, PhD

Role: PRINCIPAL_INVESTIGATOR

Hartford HealthCare

Locations

UCONN Health Center

Farmington, Connecticut, United States

Hartford Hospital

Hartford, Connecticut, United States

Countries

United States

Other Identifiers

3R01DA036486-02S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HHC-2015-0128

Identifier Type: -

Identifier Source: org_study_id