Tailored Smoking Cessation Intervention in Promoting Sexual and Gender Minority Smokers to Quit Smoking

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-10

Study Completion Date

2020-03-25

Brief Summary

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This trial studies how well tailored smoking cessation intervention works in promoting sexual and gender minority smokers to quit smoking. A program that is specifically designed for the lesbian, gay, bisexual, and transgender community may affect these participants differently than a traditional approach.

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Detailed Description

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PRIMARY OBJECTIVES:

I. To test the feasibility of two different approaches for smoking cessation (print materials developed for smoking cessation among the mainstream population versus \[vs.\] an individualized text based approach) among 60 lesbian, gay, bisexual, and transgender (LGBT) smokers.

SECONDARY OBJECTIVES:

I. To assess the levels of helpfulness, appropriateness, and perceived difficulty of the above mentioned cessation approaches among 60 LGBT smokers.

EXPLORATORY OBJECTIVES:

I. To test the smoking abstinence rates of two different individualized intensive cessation approaches (mainstream vs. individually-tailored) among 60 LGBT smokers.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants receive mainstream instructional care including brief advice on how to quit smoking, 10-week supply of nicotine replacement therapy (NRT) in the form of nicotine patches, and intensive print materials to promote smoking cessation.

ARM II: Participants receive tailored intensive care including brief advice on how to quit smoking, NRT, and intensive print materials to promote smoking cessation as in Arm I. Participants also receive individualized text based messages to promote smoking cessation for 6 months.

After completion of study, participants are followed up at 3 and 6 months.

Conditions

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Cigarette Smoker Current Every Day Smoker

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arm I (mainstream instructional care)

Participants receive mainstream instructional care including brief advice on how to quit smoking, 10-week supply of NRT in the form of nicotine patches, and intensive print materials to promote smoking cessation.

Group Type ACTIVE_COMPARATOR

Informational Intervention

Intervention Type OTHER

Receive advice to quit smoking and materials to promote smoking cessation

Arm II (tailored intensive care)

Participants receive tailored intensive care including brief advice on how to quit smoking, NRT, and intensive print materials to promote smoking cessation as in Arm I. Participants also receive individualized text based messages to promote smoking cessation for 6 months.

Group Type EXPERIMENTAL

Informational Intervention

Intervention Type OTHER

Receive advice to quit smoking and materials to promote smoking cessation

Telephone-Based Intervention

Intervention Type BEHAVIORAL

Receive individualized text based messages

Interventions

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Informational Intervention

Receive advice to quit smoking and materials to promote smoking cessation

Intervention Type OTHER

Telephone-Based Intervention

Receive individualized text based messages

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Male or female owning a cell phone with a reachable contact number
* Self-identified as LGBT individual, regardless human immunodeficiency virus (HIV) serologic status
* Smoked at least 100 cigarettes in lifetime
* Currently smoking at least 5 cigarettes a day, on average
* Willing to set a quit smoking date within a week of the enrollment
* English speaking

Exclusion Criteria

* Expired carbon monoxide (CO) levels below 7 ppm
* Positive history of a medical condition that precludes use of the nicotine patch (e.g., recent myocardial infarction, significant skin disorder, previous severe adverse reaction to nicotine patch, pregnant or breast feeding, assessed with our standard protocol for determining NRT eligibility)
* Current use of NRT or other smoking cessation medications (e.g., varenicline or bupropion)
* Pregnant or nursing
* Enrolled in another smoking cessation program
* Partner enrolled on current study

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes