Clinical trial NCT01633567: Culturally Targeted & Individually Tailored Smoking Cessation Study: LGBT Smokers
Official title: A Culturally Targeted and Individually Tailored Smoking Cessation Intervention for LGBT Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Keywords: Smoking Cessation
Cigarette Smoking
Tobacco
LGBT
LGBTQ
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Cancer Institute (NCI)
name: Howard Brown Health Center
First posted: 2012-07-04
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 7-Day Point Prevalence Smoking Quit Rates 1 Month Post Quit Date
timeFrame: Assessed 1 month after quit date
measure: 7-Day Point Prevalence Smoking Quit Rates 3 Months Post Quit Date
timeFrame: Assessed 3 months after quit date
measure: 7-Day Point Prevalence Smoking Quit Rates 6 Months Post Quit Date
timeFrame: Assessed 6 months after quit date
measure: 7-Day Point Prevalence Smoking Quit Rates 12 Months Post Quit Date
timeFrame: Assessed 12 months after quit date
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Howard Brown Health Center
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Alicia K Matthews, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Matthews AK, McConnell EA, Li CC, Vargas MC, King A. Design of a comparative effectiveness evaluation of a culturally tailored versus standard community-based smoking cessation treatment program for LGBT smokers. BMC Psychol. 2014 May 30;2(1):12. doi: 10.1186/2050-7283-2-12. eCollection 2014.