Evaluation of Cessation Preferences of Menthol Smokers

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Other: Non-flavored 2mg nicotine gum; Other: Non-flavored 4mg nicotine gum; Other: Mint-flavored 2mg nicotine gum; Other: Mint-flavored 4mg nicotine gum; Other: Non-flavored nicotine inhaler; Other: Mint-flavored nicotine ihaler

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Masonic Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: non-flavored 2mg nicotine gum; All subjects will test six different nicotine replacement products over the course of the 2-week product sampling phase. The six nicotine replacement products being tested are non-flavored 2mg nicotine gum, non-flavored 4mg nicotine gum, mint-flavored 2mg nicotine gum, mint-flavored 4mg nicotine gum, non-flavored nicotine inhaler and mint-flavored inhaler. The order in which the subjects test these products will be randomized and subjects will be blinded to the nicotine content of the product but will be instructed about the flavor of the product.	Other: Non-flavored 2mg nicotine gum
Experimental: non-flavored 4mg nicotine gum; All subjects will test six different nicotine replacement products over the course of the 2-week product sampling phase. The six nicotine replacement products being tested are non-flavored 2mg nicotine gum, non-flavored 4mg nicotine gum, mint-flavored 2mg nicotine gum, mint-flavored 4mg nicotine gum, non-flavored nicotine inhaler and mint-flavored inhaler. The order in which the subjects test these products will be randomized and subjects will be blinded to the nicotine content of the product but will be instructed about the flavor of the product.	Other: Non-flavored 4mg nicotine gum
Experimental: mint-flavored 2mg nicotine gum; All subjects will test six different nicotine replacement products over the course of the 2-week product sampling phase. The six nicotine replacement products being tested are non-flavored 2mg nicotine gum, non-flavored 4mg nicotine gum, mint-flavored 2mg nicotine gum, mint-flavored 4mg nicotine gum, non-flavored nicotine inhaler and mint-flavored inhaler. The order in which the subjects test these products will be randomized and subjects will be blinded to the nicotine content of the product but will be instructed about the flavor of the product.	Other: Mint-flavored 2mg nicotine gum
Experimental: mint-flavored 4mg nicotine gum; All subjects will test six different nicotine replacement products over the course of the 2-week product sampling phase. The six nicotine replacement products being tested are non-flavored 2mg nicotine gum, non-flavored 4mg nicotine gum, mint-flavored 2mg nicotine gum, mint-flavored 4mg nicotine gum, non-flavored nicotine inhaler and mint-flavored inhaler. The order in which the subjects test these products will be randomized and subjects will be blinded to the nicotine content of the product but will be instructed about the flavor of the product.	Other: Mint-flavored 4mg nicotine gum
Experimental: non-flavored nicotine inhaler; All subjects will test six different nicotine replacement products over the course of the 2-week product sampling phase. The six nicotine replacement products being tested are non-flavored 2mg nicotine gum, non-flavored 4mg nicotine gum, mint-flavored 2mg nicotine gum, mint-flavored 4mg nicotine gum, non-flavored nicotine inhaler and mint-flavored inhaler. The order in which the subjects test these products will be randomized and subjects will be blinded to the nicotine content of the product but will be instructed about the flavor of the product.	Other: Non-flavored nicotine inhaler
Experimental: mint-flavored inhaler; All subjects will test six different nicotine replacement products over the course of the 2-week product sampling phase. The six nicotine replacement products being tested are non-flavored 2mg nicotine gum, non-flavored 4mg nicotine gum, mint-flavored 2mg nicotine gum, mint-flavored 4mg nicotine gum, non-flavored nicotine inhaler and mint-flavored inhaler. The order in which the subjects test these products will be randomized and subjects will be blinded to the nicotine content of the product but will be instructed about the flavor of the product.	Other: Mint-flavored nicotine ihaler

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nicotine content preference	To determine menthol smokers' product perception and preference across 6 different types of products with varying nicotine content.	6 weeks

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Kola Okuyemi, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: December 18, 2013
• First Submitted That Met QC Criteria: December 18, 2013
• First Posted (Estimate): December 24, 2013

Study Record Updates

• Last Update Posted (Actual): May 7, 2019
• Last Update Submitted That Met QC Criteria: May 3, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: smoking cessation; menthol cigarettes
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 2013NTLS014