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18 Years
65 Years
Open (Enrolling)
Cigarette Smoking

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Trial Information

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.

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)

Type of Study:


Study Design:

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

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

Assessed 1 month after quit date

Safety Issue:


Principal Investigator

Alicia K Matthews, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Illinois


United States: Institutional Review Board

Study ID:




Start Date:

May 2012

Completion Date:

Related Keywords:

  • Cigarette Smoking
  • Smoking Cessation
  • Cigarette Smoking
  • Tobacco
  • LGBT
  • Smoking



Howard Brown Health CenterChicago, Illinois  60613