View Clinical Trial (Medical Research Study)
Culturally Targeted & Individually Tailored Smoking Cessation Study: LGBT Smokers
| City: |
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Chicago |
| State: |
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Illinois |
| Zip Code: |
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60613 |
| Conditions: |
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Cigarette Smoking |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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Inclusion Criteria:
- Self identify as lesbian, gay, bisexual, or transgender
- Age 18-65
- Current cigarette smoker (More than 5 packs in lifetime AND past year smoking AND 4
or more days per week AND CO air expired reading of ≥ 8 ppm)
- Desire to quit smoking (self-report rating of interest in quitting at least a 5 on a
10-point scale)
- 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.
Exclusion Criteria:
- Does not identify as LGBT
- Outside age range (< 18 years old or > 65 years old)
- Not current smoker
- Low desire to quit smoking (self-report rating of interest in quitting at < 5 on a
10-point scale)
- Does not agree to behavioral counseling, randomization, or follow-up
- Does not agree to use nicotine patch or has had adverse reactions to the patch
- Uncontrolled hypertension per medical screening
- Active coronary artery disease or other heart condition per medical screening
- Currently pregnant, plans to become pregnant, currently lactating, or plans for
breastfeeding over study enrollment period (i.e., 13 months) per medical screening
- Moderate to severe alcohol dependence (score of ≥ 5 on the Short Michigan Alcohol
Screening Test, SMAST)
- Substantial to severe alcohol dependence (score of ≥ 6 on the Drug Abuse Screening
Test-10, DAST)
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| NCT ID: |
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NCT01633567 |
| Primary Contact: |
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Principal Investigator
Alicia K Matthews, Ph.D.
University of Illinois
Alicia K Matthews, Ph.D.
Phone: 773-572-8360
Email: aliciak@uic.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Chicago, Illinois 60613
United States
Maria C Vargas, BA
Phone: 773-572-8360
Email: mariav@howardbrown.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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