Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Culturally Targeted & Individually Tailored Smoking Cessation Study: LGBT Smokers

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Illinois at Chicago
Sponsor:
Collaborators:
Howard Brown Health Center
Information provided by (Responsible Party):
Alicia Matthews, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT01633567
First received: May 30, 2012
Last updated: August 15, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Cigarette Smoking
Behavioral: Culturally Targeted Cessation Program
Behavioral: Non-Targeted Cessation Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • 7-Day Point Prevalence Smoking Quit Rates 1 Month Post Quit Date [ Time Frame: Assessed 1 month after quit date ] [ Designated as safety issue: No ]
    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.

  • 7-Day Point Prevalence Smoking Quit Rates 3 Months Post Quit Date [ Time Frame: Assessed 3 months after quit date ] [ Designated as safety issue: No ]
    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.

  • 7-Day Point Prevalence Smoking Quit Rates 6 Months Post Quit Date [ Time Frame: Assessed 6 months after quit date ] [ Designated as safety issue: No ]
    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.

  • 7-Day Point Prevalence Smoking Quit Rates 12 Months Post Quit Date [ Time Frame: Assessed 12 months after quit date ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 400
Study Start Date: May 2012
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Culturally Targeted Cessation Program
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.
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.
Active Comparator: Non-Targeted Cessation Program
Non-culturally targeted program with cognitive and behavioral approaches and smoking education content.
Behavioral: 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.

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01633567

Contacts
Contact: Alicia K Matthews, Ph.D. 773-572-8360 aliciak@uic.edu

Locations
United States, Illinois
Howard Brown Health Center Recruiting
Chicago, Illinois, United States, 60613
Contact: Natalie Ross, BA    773-388-8868    natalier@howardbrown.org   
Sponsors and Collaborators
University of Illinois at Chicago
Howard Brown Health Center
Investigators
Principal Investigator: Alicia K Matthews, Ph.D. University of Illinois at Chicago
  More Information

Additional Information:
No publications provided

Responsible Party: Alicia Matthews, Associate Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT01633567     History of Changes
Other Study ID Numbers: 2010-0538, R01DA023935
Study First Received: May 30, 2012
Last Updated: August 15, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Illinois at Chicago:
Smoking Cessation
Cigarette Smoking
Tobacco
LGBT
LGBTQ

ClinicalTrials.gov processed this record on November 25, 2014