Manipulating Tobacco Constituents in Female Menthol Smokers

Not Applicable

Completed

• Conditions: Nicotine Dependence
• Interventions: Other: Reduced Nicotine Content- Non Menthol; Other: Reduced Nicotine Content- Menthol; Other: Conventional Nicotine Content- Menthol; Other: Conventional Nicotine Content- Non Menthol

• Registration Number: NCT02048852
• Lead Sponsor: UConn Health

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?

Study Timeline

• Study First Submitted: 2014-01-27
• Study First Submitted QC: 2014-01-27
• Study First Posted: 2014-01-29
• Study Start: 2014-07
• Primary Completion: 2020-03
• Study Completion: 2020-07
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-18
• Last Update Posted: 2021-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 381

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Reduced Nicotine Content -Non Menthol	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.
Reduced Nicotine Content- Menthol	Reduced Nicotine Content- Menthol	Switch from own brand of cigarette to Reduced Nicotine Research Cigarettes which contain 0.07mg nicotine yield with Menthol
Conventional Nicotine Content- Menthol	Conventional Nicotine Content- Menthol	Allow own brand of Conventional Nicotine-Menthol Cigarette. No research cigarettes used.
Conventional Nicotine Content- Non Menthol	Conventional Nicotine Content- Non Menthol	Switch from own brand of cigarette to SPECTRUM research cigarette (NRC-600 Conventional Nicotine )which contains conventional nicotine yield.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States

UCONN Health Center; 🇺🇸 Farmington, Connecticut, United States