NCT02020005

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 24, 2013

Completed
Last Updated

October 3, 2025

Status Verified

October 1, 2025

Enrollment Period

3 months

First QC Date

December 18, 2013

Last Update Submit

October 1, 2025

Conditions

Smoking Cessation

Keywords

menthol cigarettessmoking cessation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Nicotine content preference

    6 weeks

Study Arms (6)

non-flavored 2mg nicotine gum

EXPERIMENTAL

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

non-flavored 4mg nicotine gum

EXPERIMENTAL

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

mint-flavored 2mg nicotine gum

EXPERIMENTAL

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

mint-flavored 4mg nicotine gum

EXPERIMENTAL

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

non-flavored nicotine inhaler

EXPERIMENTAL

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

mint-flavored inhaler

EXPERIMENTAL

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

Interventions

Non-flavored 2mg nicotine gumOTHER
non-flavored 2mg nicotine gum
Non-flavored 4mg nicotine gumOTHER
non-flavored 4mg nicotine gum
Mint-flavored 2mg nicotine gumOTHER
mint-flavored 2mg nicotine gum
Mint-flavored 4mg nicotine gumOTHER
mint-flavored 4mg nicotine gum
Non-flavored nicotine inhalerOTHER
non-flavored nicotine inhaler
Mint-flavored nicotine ihalerOTHER
mint-flavored inhaler

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Nicotine Chewing Gum

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Chewing GumPlant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesTobacco Use Cessation DevicesTherapeuticsCandyFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Kola Okuyemi, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2013

First Posted

December 24, 2013

Study Start

September 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

October 3, 2025

Record last verified: 2025-10

Locations

US(1)