Manipulating Tobacco Constituents in Female Menthol Smokers

UConn Health

Status: Completed

Conditions: Nicotine Dependence

Treatments: Other: Conventional Nicotine Content- Non Menthol; Other: Reduced Nicotine Content- Non Menthol; Other: Conventional Nicotine Content- Menthol; Other: Reduced Nicotine Content- Menthol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02048852

H14-120-1

1R01DA036486-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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?

Enrollment: 381 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria are:

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 are:

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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381 participants in 4 patient groups

Reduced Nicotine Content -Non Menthol

Experimental group

Description:

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

Treatment:

Other: Reduced Nicotine Content- Non Menthol

Reduced Nicotine Content- Menthol

Experimental group

Description:

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

Treatment:

Other: Reduced Nicotine Content- Menthol

Conventional Nicotine Content- Menthol

Active Comparator group

Description:

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

Treatment:

Other: Conventional Nicotine Content- Menthol

Conventional Nicotine Content- Non Menthol

Experimental group

Description:

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

Treatment:

Other: Conventional Nicotine Content- Non Menthol