Culturally Targeted & Individually Tailored Smoking Cessation Study: LGBT Smokers

University of Illinois

Status: Completed

Conditions: Cigarette Smoking

Treatments: Behavioral: Culturally Targeted Cessation Program; Behavioral: Non-Targeted Cessation Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01633567

2010-0538

R01DA023935 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Culturally Targeted Cessation Program

Experimental group

Description:

The culturally targeted program will include the same cognitive and behavioral approaches and smoking education content that is used in the standard program. As such, we will maintain the integrity of the core program. However, cultural targeting of that program has been informed by local LGBT focus group input and testing, the available literature on LGBT smoking rates and behaviors, feedback from a panel of LGBT health experts, and data collected as part of a previous study.

Treatment:

Behavioral: Culturally Targeted Cessation Program

Non-Targeted Cessation Program

Active Comparator group

Description:

Non-culturally targeted program with cognitive and behavioral approaches and smoking education content.

Treatment:

Behavioral: Non-Targeted Cessation Program