Evaluation of Cessation Preferences of Menthol Smokers

Smoking Cessation Clinical Trial

Official title:

Evaluation of Cessation Preferences of Menthol Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02020005
• Other study ID #: 2013NTLS014
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: December 2013

Study information

• Verified date: May 2019
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary aim of this study is to determine menthol smokers' perception, product preference, and pattern of use across six products including, mint-flavored nicotine gum; non-flavored nicotine gum; mentholated nicotine inhaler; and non-menthol nicotine inhaler. Participants will undergo an orientation and baseline assessment followed by a 2-week product sampling phase. At the end of the 2 weeks of sampling, subjects will select a product to use during the following 2-week smoking cessation phase. This 2-week abstinence phase is followed by one week of abrupt withdrawal of the product. This study design was successfully used in a study we conducted that examined the smokers' preference for a variety or oral tobacco products.

Other known NCT identifiers

• NCT01978197

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Self-identified as African American or Black;

• Aged 18 years or older;

• High school graduate or GED;

• Smoking at least 10 cigarettes daily for the past year;

• Usually smoked mentholated cigarette brand (greater than 80% of the time) in the past two years;

• Good physical health (no unstable medical condition);

• No contraindications for nicotine inhaler or gum use, such as mouth sores or significant dental or jaw problems;

• Stable, good health.

Exclusion Criteria:

• Recent unstable or untreated psychiatric diagnosis including substance abuse, as determined by the DSM-IV criteria;

• Currently using other tobacco or nicotine products other than cigarettes;

• Pregnant or nursing.

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Other:
• Non-flavored 2mg nicotine gum

• Non-flavored 4mg nicotine gum

• Mint-flavored 2mg nicotine gum

• Mint-flavored 4mg nicotine gum

• Non-flavored nicotine inhaler

• Mint-flavored nicotine ihaler

Locations

Country	Name	City	State
United States	University of Minnesota Masonic Cancer Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Product preference for nicotine replacement	To determine menthol smokers' product perception and preference across 6 different types of products with varying mint content.	6 weeks
Secondary	Nicotine content preference	To determine menthol smokers' product perception and preference across 6 different types of products with varying nicotine content.	6 weeks