Nicotine Dependence
Conditions
Keywords
menthol, nicotine
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?
Interventions
OTHERReduced 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.
OTHERReduced Nicotine Content- Menthol
Switch from own brand of cigarette to Reduced nicotine level of each research cigarette to 0.07mg nicotine yield with Menthol
OTHERConventional Nicotine Content- Menthol
Allow own brand of Conventional Nicotine-Menthol Cigarette
OTHERConventional Nicotine Content- Non Menthol
Switch from own cigarette to a research cigarette which contains Conventional Nicotine yield.
Sponsors
National Institute on Drug Abuse (NIDA)
UConn Health
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The goal of the cigarette conditions is to find the impact of varying nicotine and menthol concentrations on smoking rate and abstinence. | 12 weeks | Alter the nicotine and menthol concentrations of cigarettes administered to subjects as randomized. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Toxicant Exposure | 12 weeks | Examine the effects of reduced nicotine and menthol removal on toxicant exposure for the outcomes-- cotinine, exhaled carbon monoxide, and urine carcinogens and other tobacco specific nitrosamines. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cigarette content manipulations effect on a model mediating usage | 12 Weeks | Examine cigarette content manipulation (nicotine reduction and menthol removal) as independent variables and the number of cigarettes recorded daily as dependent variable..Measures that will be tested for include subscales of the cigarette evaluations as well as craving, affect and mood, and self-confidence |
| Effect of taster status | 12 Weeks | To explore the moderating effects of supertasters with menthol assignments to predict compliance with treatment, cigarette taste and aversion. A logistic model will be used to predict post-treatment abstinence. The interaction between supertaster and menthol will test for the moderating effect. |
Countries
United States
Outcome results
None listed