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Completed

NCT Number: NCT04461288

Engaging Sexual and Gender Minority Cigarette Smokers Into Social Media-based Treatment

This research study will evaluate the preliminary efficacy of Pride Posts Plus, a social media-based smoking cessation treatment. A pilot randomized trial (N=120) will compare Pride Posts Plus, which includes a gamification element, to Pride Posts (without gamification) and to a usual care treatment. Participants will be adults who smoke, identify as sexual or gender minorities, and use Facebook. The primary outcome will be biochemically verified 7-day abstinence from smoking at 3 and 6 months. Secondary outcomes will be treatment engagement, a quit attempt (y/n), and thoughts about tobacco abstinence at 3 and 6 mos.

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Key information

Conditions

Smoking Cessation Behavior Chemically-Induced Disorders Cigarette Smoking Coitus Health Behavior Mental Disorders Nicotine Dependence Sexual Behavior Smoking Substance-Related Disorders Tobacco Smoking Tobacco Use Tobacco Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

About this study

Participants (N=136) will be randomized to one of three conditions: (1) Pride Posts, a Facebook-delivered smoking cessation intervention (including daily posts, and weekly live group sessions, tailored to sexual and gender minority (SGM) adults; (2) Pride Posts Plus, the Facebook-delivered smoking cessation intervention plus a gamification element, or (2) a usual care condition which includes referral to smokefree.gov, a federally-developed web-based intervention which includes similar digital treatment elements. All participants will have access to up to six months of nicotine replacement therapy (NRT).

Assessments will occur at baseline, 3, and 6 months follow-up. Assessments will include measures on smoking, thoughts about abstinence, and SGM identity experiences. All participants who report no past 7-day smoking will be asked to provide biochemical verification of smoking status using a portable carbon monoxide measurement tool. All intervention and assessment procedures will be conducted digitally.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Daily smoker
  • Self-identify as sexual and/or gender minority
  • Interested in quitting in next 6 months
  • 6 months of Facebook experience
  • English-speaking

Exclusion criteria

  • Contraindications to nicotine replacement therapy

Treatment and study plan

Social media-based education, counseling, and support

Behavioral

This six-month intervention is culturally-tailored to sexual and gender minority cigarette smokers. The intervention is group-based and includes daily posts and weekly live sessions during the initial three months. Posts and group sessions focus on tobacco use education, developing a quit plan, as well as managing stress, negative thinking, social support, exercise, as techniques to support cessation.

Nicotine replacement therapies (NRT)

Other

Participants will have access to up to six months of nicotine patch therapy. Participants will start on either 21, 14, or 7 mg patches based on manufacturers recommendations based on smoking behaviors.

In addition to nicotine patch, participants will have access to a choice of 2 mg. nicotine lozenges or nicotine gum as an adjunct to patch treatment. Participants will be encouraged to use up to 5 pieces daily to address situational urges and cravings for a cigarette.

Gamification

Other

Gaming elements designed to encourage participation in the program and behavior change.

Primary outcomes

  1. Number of Participants With Reported 7-day Biochemically Verified Abstinence at 3 Months

    Time frame: 3 months

    Abstinence is defined by all participants who report no smoking within the last 7 days will use a breathalyzer to measure carbon monoxide levels in the breath to verify smoking abstinence prior to the 3 month assessment.

  2. Number of Participants With Reported 7-day Biochemically Verified Abstinence at 6 Months

    Time frame: 6 months

    Abstinence is defined by all participants who report no smoking within the last 7 days will use a breathalyzer to measure carbon monoxide levels in the breath to verify smoking abstinence prior to the 6 month assessment.

Secondary outcomes

  1. Number of Participants Whom Attempted to Quit Tobacco Use During the Course of Treatment

    Time frame: 3 to 6 months

    Participants will report intentional quit attempts lasting at least 24 hours since treatment initiation or previous assessment

  2. Responses to the Thoughts About Abstinence Questionnaire Over Time

    Time frame: 3 to 6 months

    The Thoughts About Abstinence Questionnaire is a 5 item self-report questionnaire that measures: 1) desire to quit smoking, 2) expected success at quitting, 3) expected difficulty of quitting, and 4) confidence in ability to quit on 10-point Likert scales (e.g., 1=no desire to quit/lowest expectation/lowest level of difficulty to 10 = extreme desire to quit/highest expectation of success/highest expected difficulty.

  3. Frequency of social media posts

    Time frame: 3 to 6 months

    Treatment engagement as measured by frequency of social media posts

  4. Frequency of participation in live group sessions

    Time frame: 3 to 6 months

    Treatment engagement as measured by participation in live group sessions

  5. Duration of Active Participation

    Time frame: 3 to 6 months

    Treatment engagement as measured by duration of active participation in intervention.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Tobacco Related Disease Research Program

Registry information

Official study title

Social Media-Based Treatment: Engaging Sexual and Gender Minority Smokers

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 8, 2020
Registry last updated
Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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