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

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04461288
• Other study ID #: TRDRP - T29IP0461
• Status: Completed
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: May 30, 2022

Study information

• Verified date: September 2022
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: May 30, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoking
• Nicotine Dependence
• Smoking Cessation
• Tobacco Use
• Tobacco Use Disorder

Intervention

Behavioral:
• Social media-based education, counseling, and support
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.

Other:
• Nicotine replacement therapies (NRT)
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
Gaming elements designed to encourage participation in the program and behavior change.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Tobacco Related Disease Research Program

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Reported 7-day Biochemically Verified Abstinence at 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.	3 months
Primary	Number of Participants With Reported 7-day Biochemically Verified Abstinence at 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.	6 months
Secondary	Number of Participants Whom Attempted to Quit Tobacco Use During the Course of Treatment	Participants will report intentional quit attempts lasting at least 24 hours since treatment initiation or previous assessment	3 to 6 months
Secondary	Responses to the Thoughts About Abstinence Questionnaire Over Time	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 to 6 months
Secondary	Frequency of social media posts	Treatment engagement as measured by frequency of social media posts	3 to 6 months
Secondary	Frequency of participation in live group sessions	Treatment engagement as measured by participation in live group sessions	3 to 6 months
Secondary	Duration of Active Participation	Treatment engagement as measured by duration of active participation in intervention.	3 to 6 months