Informing Tobacco Treatment Guidelines for African American Non-Daily Smokers

University of Kansas

Status and phase: Completed; Phase 4

Conditions: Smoking Cessation

Treatments: Behavioral: Smoking Cessation Counseling; Drug: Nicotine Replacement Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02244918

STUDY00001602

AD-1310-08709 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 278 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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278 participants in 2 patient groups

Counseling

Active Comparator group

Description:

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

Treatment:

Behavioral: Smoking Cessation Counseling

Counseling Plus NRT

Experimental group

Description:

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.

Treatment:

Behavioral: Smoking Cessation Counseling

Drug: Nicotine Replacement Therapy