Skip to main content
OpenTrials
Completed

NCT Number: NCT01633567

Culturally Targeted & Individually Tailored Smoking Cessation Study: LGBT Smokers

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cigarette Smoking Behavior Health Behavior Smoking Smoking Cessation Tobacco Smoking Tobacco Use

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Howard Brown Health Center

Chicago, Illinois, 60613, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Culturally Targeted Cessation Program

Behavioral

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

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.

Primary outcomes

  1. 7-Day Point Prevalence Smoking Quit Rates 1 Month Post Quit Date

    Time frame: Assessed 1 month after 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.

  2. 7-Day Point Prevalence Smoking Quit Rates 3 Months Post Quit Date

    Time frame: Assessed 3 months after 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.

  3. 7-Day Point Prevalence Smoking Quit Rates 6 Months Post Quit Date

    Time frame: Assessed 6 months after 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.

  4. 7-Day Point Prevalence Smoking Quit Rates 12 Months Post Quit Date

    Time frame: Assessed 12 months after 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.

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • Howard Brown Health Center
  • National Cancer Institute (NCI)
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jul 4, 2012
Registry last updated
May 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.