Culturally Targeted & Individually Tailored Smoking Cessation Study: LGBT Smokers

Cigarette Smoking Clinical Trial

Official title:

A Culturally Targeted and Individually Tailored Smoking Cessation Intervention for LGBT Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01633567
• Other study ID #: 2010-0538
• Secondary ID: R01DA023935
• Status: Completed
• Phase: N/A
• First received: May 30, 2012
• Last updated: May 3, 2017
• Start date: May 2012
• Est. completion date: January 2016

Study information

• Verified date: May 2017
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

For the approximately 4.6 million LGBT persons in the U.S., smoking rates among those living in urban areas are roughly twice that of heterosexuals. Targeted interventions have shown great promise in reducing health risk behaviors across a variety of behaviors and population groups by enhancing the relevance of the health information. The primary aim of this study is to test the efficacy of a culturally targeted group-based smoking cessation intervention (vs. a non-targeted intervention) on smoking outcomes among lesbian, gay, bisexual, and transgender (LGBT) smokers. The investigators anticipate that the culturally targeted intervention will be more effective at helping LGBT smokers to successfully stop smoking than will the non-targeted intervention.

Description:

In Phase 1 of this study we used focus groups to establish the cultural appropriateness and acceptability of the targeted elements of the intervention for the LGBT population. For Phase 2 of this study, we seek to enroll 400 participants in a randomized controlled trial of the targeted intervention vs. a non-targeted, comparison condition. Both conditions will consist of group counseling sessions combined with nicotine replacement therapy and peer support. We expect that quit rates, stage of readiness, perceived benefits, self-efficacy, and treatment adherence will be higher among those who received the targeted intervention than those in the non-targeted intervention. Furthermore, we expect that a stronger LGBT cultural identification and salience of that identity will be associated with more satisfaction and adherence to the targeted intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Self identify as lesbian, gay, bisexual, or transgender

• Age 18-65

• Current cigarette smoker

• Desire to quit smoking (self-report rating of interest in quitting)

• Relatively healthy, with no medical conditions that would adversely interact with study parameters (see exclusion criteria for specific details)

• Agree to attend behavioral counseling sessions, be randomized, and be followed-up

• Agrees to use nicotine patch and has no prior adverse reactions to patch

• Has stable residence and telephone and can provide the name of an outside household collateral family member or close friend for contact and follow-up.

Related Conditions & MeSH terms

• Cigarette Smoking

Intervention

Behavioral:
• Culturally Targeted Cessation Program
The culturally targeted version of the behavioral counseling intervention will consist of six group-based smoking cessation counseling sessions. Each smoking cessation therapy session will last approximately 90 minutes and will begin two weeks before the quit date. In addition, participants will be provided nicotine replacement therapy and peer support sessions will occur between the group sessions.
• Non-Targeted Cessation Program
Behavioral counseling intervention will consist of six group-based smoking cessation counseling sessions. Each smoking cessation therapy session will last approximately 90 minutes and will begin two weeks before the quit date. In addition, participants will be provided nicotine replacement therapy and peer support sessions will occur between the group sessions.

Locations

Country	Name	City	State
United States	Howard Brown Health Center	Chicago	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
University of Illinois at Chicago	Howard Brown Health Center, National Cancer Institute (NCI), National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-Day Point Prevalence Smoking Quit Rates 1 Month Post Quit Date	7-Day point prevalence smoking quit rates will serve as the main outcome measure and will be obtained from Time Line Follow-Back (TLFB) interviews.	Assessed 1 month after quit date
Primary	7-Day Point Prevalence Smoking Quit Rates 3 Months Post Quit Date	7-Day point prevalence smoking quit rates will serve as the main outcome measure and will be obtained from Time Line Follow-Back (TLFB) interviews.	Assessed 3 months after quit date
Primary	7-Day Point Prevalence Smoking Quit Rates 6 Months Post Quit Date	7-Day point prevalence smoking quit rates will serve as the main outcome measure and will be obtained from Time Line Follow-Back (TLFB) interviews.	Assessed 6 months after quit date
Primary	7-Day Point Prevalence Smoking Quit Rates 12 Months Post Quit Date	7-Day point prevalence smoking quit rates will serve as the main outcome measure and will be obtained from Time Line Follow-Back (TLFB) interviews.	Assessed 12 months after quit date

External Links

•   Research Partner Agency
•   University of Illinois at Chicago Website