Clinical trial NCT02048852: Manipulating Tobacco Constituents in Female Menthol Smokers
Official title: Manipulating Tobacco Constituents in Female Menthol Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Dependence
Keywords: menthol
nicotine
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2014-01-29
Enrollment: 381
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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?

Eligibility 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.

Primary outcomes:
measure: The goal of the cigarette conditions is to find the impact of varying nicotine and menthol concentrations on smoking rate and abstinence.
timeFrame: 12 weeks
Secondary outcomes:
measure: Toxicant Exposure
timeFrame: 12 weeks
Other outcomes:
measure: Cigarette content manipulations effect on a model mediating usage
timeFrame: 12 Weeks
measure: Effect of taster status
timeFrame: 12 Weeks
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 Center
name: Cheryl A Oncken, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: