Informing Tobacco Treatment Guidelines for African American Non-Daily Smokers

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

278 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2018-03-15

Brief Summary

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The researchers are testing if counseling alone or counseling plus over-the-counter nicotine replacement therapies (NRT), like the patch,gum, or lozenge, helps African American non-daily smokers quit smoking.

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Detailed Description

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Non-daily smokers represent a growing number of racial/ethnic minority smokers. 1 out of 4 African Americans are non-daily smokers. African Americans seem to have a harder time quitting and have greater medical problems related to smoking even at lighter usage rates compared to Whites.

Current tobacco treatment guidelines target daily smokers. There are no guidelines for non-daily smokers. This study will allow the researchers to explore treatment options for African American non-daily smokers and find out if some treatments work better than others.

Participation in this study will last about 6 months. Over this course of time, participants will be asked to visit the study location 3 times and will talk with a member of the study team on the phone 4 times.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Counseling

Participants will go to smoking cessation counseling over 12 weeks. They will be asked to participated in 5 total counseling sessions.

Group Type ACTIVE_COMPARATOR

Smoking Cessation Counseling

Intervention Type BEHAVIORAL

Counseling Plus NRT

Participants will go to smoking cessation counseling over 12 weeks. They will be asked to participated in 5 total counseling sessions. In addition to counseling, participants in this group will also take 12 weeks of a nicotine replacement therapy(NRT) (like the patch, gum or lozenge) of their choice.

Group Type EXPERIMENTAL

Nicotine Replacement Therapy

Intervention Type DRUG

Participant has choice of from over-the-counter nicotine patch, nicotine gum or lozenge.

Smoking Cessation Counseling

Intervention Type BEHAVIORAL

Interventions

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Nicotine Replacement Therapy

Participant has choice of from over-the-counter nicotine patch, nicotine gum or lozenge.

Intervention Type DRUG

Smoking Cessation Counseling

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* African American adults who are interested in quitting and whose smoking patterns meet criteria for non-daily smoking as determined by eligibility screening

Exclusion Criteria

* Contraindications to behavioral counseling, nicotine gum, patch, or lozenge and unable to complete study procedures as determined by eligibility screening

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes