Manipulating Tobacco Constituents in Female Menthol Smokers

Nicotine Dependence Clinical Trial

— Menthol  

Official title:

Manipulating Tobacco Constituents in Female Menthol Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02048852
• Other study ID #: H14-120-1
• Secondary ID: 1R01DA036486-01
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: July 2020

Study information

• Verified date: March 2021
• Source: UConn Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 381
• Est. completion date: July 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

Intervention

Other:
• 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.
• 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
• Conventional Nicotine Content- Menthol
Allow own brand of Conventional Nicotine-Menthol Cigarette
• Conventional Nicotine Content- Non Menthol
Switch from own cigarette to a research cigarette which contains Conventional Nicotine yield.

Locations

Country	Name	City	State
United States	UCONN Health Center	Farmington	Connecticut
United States	Hartford Hospital	Hartford	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
UConn Health	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cigarette content manipulations effect on a model mediating usage	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	12 Weeks
Other	Effect of taster status	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.	12 Weeks
Primary	The goal of the cigarette conditions is to find the impact of varying nicotine and menthol concentrations on smoking rate and abstinence.	Alter the nicotine and menthol concentrations of cigarettes administered to subjects as randomized.	12 weeks
Secondary	Toxicant Exposure	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.	12 weeks