Manipulating Tobacco Constituents in Female Menthol Smokers

NCT ID: NCT02048852

Last Updated: 2021-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 381 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2020-07-31

Brief Summary

This study examines the potential effect of reducing nicotine content or menthol or both in women of reproductive age, a vulnerable population identified by the FDA in need of further research.

Detailed Description

Study is designed to address the following questions that have been outlined by the FDA as particular areas of interest:

1. What are the factors, including menthol and other flavorings that influence the appeal of tobacco products to vulnerable populations: What is the impact of these factors on cessation, switching tobacco products and multiple use?

2. What is the potential impact of modifying nicotine levels on dependence, and smoking rate and cessation, as well as patterns of switching products and use of multiple tobacco products?

3. Beyond nicotine, what other constituents enhance addictive properties?

Conditions

Nicotine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Reduced Nicotine Content -Non Menthol

Switch from own brand of cigarette to SPECTRUM research cigarettes (NRC 200-Reduced Nicotine Content cigarette) which contain 0.07mg nicotine yield without menthol.

Group Type: EXPERIMENTAL

Reduced Nicotine Content- Non Menthol

Intervention Type: OTHER

Switch from own brand of cigarette to a research cigarette with a Reduced Nicotine Content of 0.07mg nicotine yield without menthol.

Reduced Nicotine Content- Menthol

Switch from own brand of cigarette to Reduced Nicotine Research Cigarettes which contain 0.07mg nicotine yield with Menthol

Group Type: EXPERIMENTAL

Reduced Nicotine Content- Menthol

Intervention Type: OTHER

Switch from own brand of cigarette to Reduced nicotine level of each research cigarette to 0.07mg nicotine yield with Menthol

Conventional Nicotine Content- Menthol

Allow own brand of Conventional Nicotine-Menthol Cigarette. No research cigarettes used.

Group Type: ACTIVE_COMPARATOR

Conventional Nicotine Content- Menthol

Intervention Type: OTHER

Allow own brand of Conventional Nicotine-Menthol Cigarette

Conventional Nicotine Content- Non Menthol

Switch from own brand of cigarette to SPECTRUM research cigarette (NRC-600 Conventional Nicotine )which contains conventional nicotine yield.

Group Type: EXPERIMENTAL

Conventional Nicotine Content- Non Menthol

Intervention Type: OTHER

Switch from own cigarette to a research cigarette which contains Conventional Nicotine yield.

Interventions

Reduced Nicotine Content- Non Menthol

Switch from own brand of cigarette to a research cigarette with a Reduced Nicotine Content of 0.07mg nicotine yield without menthol.

Intervention Type: OTHER

Reduced Nicotine Content- Menthol

Switch from own brand of cigarette to Reduced nicotine level of each research cigarette to 0.07mg nicotine yield with Menthol

Intervention Type: OTHER

Conventional Nicotine Content- Menthol

Allow own brand of Conventional Nicotine-Menthol Cigarette

Intervention Type: OTHER

Conventional Nicotine Content- Non Menthol

Switch from own cigarette to a research cigarette which contains Conventional Nicotine yield.

Intervention Type: OTHER

Other Intervention Names

SPECTRUM Research Cigarette - NRC 200; SPECTRUM Research Cigarette - RNC 201; Own brand of Conventional Nicotine-Menthol Cigarette; 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. female 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 by patient or identified in medical record 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 (based on history and drug and alcohol questionaires) or other heart conditions. The study physician will determine whether a given medical condition is unstable and the appropriateness of study participation for a particular subject;

7. Serious quit attempts in the last 3 months (to ensure stability of smoking);

8. regular use (e.g., greater than weekly) of tobacco products other than cigarettes;

9. Currently using nicotine replacement or other tobacco cessation products (to minimize confounding effects of another product);

10. Pregnant or breastfeeding those planning to become pregnant,and those who are of childbearing potential and are not using an "acceptable form" of birthcontrol such as Depo-provera, Norplant, tubal ligation and barrier methods such as condoms or diaphragm.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• 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 A Oncken, MD MPH

Role: PRINCIPAL_INVESTIGATOR

UCONN Health Center

Locations

UCONN Health Center

Farmington, Connecticut, United States

Hartford Hospital

Hartford, Connecticut, United States

Countries

United States

Other Identifiers

1R01DA036486-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H14-120-1

Identifier Type: -

Identifier Source: org_study_id