Evaluation of Cessation Preferences of Menthol Smokers

• ClinicalTrials.gov Identifier: NCT02020005
• Recruitment Status: Completed
• First Posted: December 24, 2013
• Last Update Posted: May 7, 2019
• Sponsor: University of Minnesota
• Information provided by (Responsible Party): University of Minnesota

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Smoking Cessation	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	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Evaluation of Cessation Preferences of Menthol Smokers
• Study Start Date: September 2013
• Actual Primary Completion Date: December 2013
• Actual Study Completion Date: December 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Product preference for nicotine replacement [ Time Frame: 6 weeks ]
   To determine menthol smokers' product perception and preference across 6 different types of products with varying mint content.

Secondary Outcome Measures :

1. Nicotine content preference [ Time Frame: 6 weeks ]
   To determine menthol smokers' product perception and preference across 6 different types of products with varying nicotine content.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, Minnesota

University of Minnesota Masonic Cancer Center

Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

University of Minnesota

Investigators

• Principal Investigator: Kola Okuyemi, MD; University of Minnesota

More Information

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT02020005
• Obsolete Identifiers: NCT01978197
• Other Study ID Numbers: 2013NTLS014
• First Posted: December 24, 2013
• Last Update Posted: May 7, 2019
• Last Verified: May 2019

Keywords provided by University of Minnesota:

menthol cigarettes; smoking cessation

Additional relevant MeSH terms:

Nicotine; Ganglionic Stimulants; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Nicotinic Agonists; Cholinergic Agonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action