Project QUIT+: Adapting and Testing a Smoking Cessation Intervention for Transgender and Gender Expansive Individuals

NCT06654414 | Terminated DMC

• 2 other identifiers: IRB2024-31R21CA292185-01
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 3

Brief Summary

Smoking remains the leading preventable cause of death in the United States, and there are persistent and significant disparities in tobacco use among transgender and gender diverse (TGD) individuals. Stigma, discrimination, gender dysphoria, and other gender minority stressors likely contribute to these disparities, and the increased burden of gender minority stress may also be driving higher prevalence rates of anxiety and depression, both of which are more common among TGD individuals and among those who smoke relative to comparison samples. This study will (1) explore the ways in which gender minority stressors and associated anxiety and depression compromise smoking cessation among TGD individuals, identifying elements in an existing smoking cessation intervention that need to be adjusted to meet their unique needs; (2) adapt an existing smoking cessation intervention for TGD individuals; and (3) evaluate the feasibility and acceptability of the adapted intervention in a pilot randomized controlled trial.

Conditions

Smoking Cessation; Depression; Anxiety; Nicotine Dependence; Gender Minority Stress

Keywords

Smoking Cessation; Smoking; Tobacco Use; Tobacco Use Disorder; Substance-Related Disorder; Nicotine; Anxiety; Depression; Transgender Individuals; Gender Expansive Individuals; Gender Minority Stress; Distress Tolerance; Quitting; Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (2)

• Acceptability

  Acceptability will be assessed via a questionnaire, completed after every other treatment session, that measures the 7 constructs of the acceptability of health care interventions framework: affective attitude, burden, ethicality, coherence, opportunity costs, perceived effectiveness, and self-efficacy. The intervention will be deemed acceptable if at least 75% of the participants rate 4+ items on the acceptability questionnaires with a 4 or a 5 on the Likert-style scale.

  Through the end of treatment intervention, approximately 10 weeks

• Feasibility

  Feasibility of the intervention is a primary outcome measure that will be calculated based on three assessments: (1) interventionist fidelity to the protocol (via a review of 10% of session recordings to determine whether key themes were addressed), (2) session attendance, and (3) participant retention at follow-up. Feasibility will be demonstrated if at least (1) 80% of the reviewed sessions address all key themes, (2) 75% of the participants attend at least half of all treatment sessions; and (3) 70% of the participants complete the 3-month follow-up.

  Through participants' enrollment, approximately 6 months

Secondary Outcomes (8)

• 7-Day Point Prevalence Abstinence

  At the end of treatment intervention (approx. 10 weeks post-baseline) and at 3-month follow-up (T3; approx. 6 months post-baseline)

• Gender Minority Stress

  At baseline assessment, end of treatment intervention (approx. 10 weeks post-baseline), and 3-month follow-up (T3; approx. 6 months post-baseline)

• Average Number of Cigarettes Smoked Per Day In The Past Week

  At baseline assessment, end of treatment intervention (approx. 10 weeks post-baseline), and 3-month follow-up (T3; approx. 6 months post-baseline)

• Nonbinary Distal Stress (Nbi-DMSS )

  At baseline assessment, end of treatment intervention (approx. 10 weeks post-baseline), and 3-month follow-up (T3; approx. 6 months post-baseline)

• Proximal Minority Stress (Nbi-PMSS)

  At baseline assessment, end of treatment intervention (approx. 10 weeks post-baseline), and 3-month follow-up (T3; approx. 6 months post-baseline)

Study Arms (2)

PRIDE QUIT

EXPERIMENTAL

Participants in this adapted intervention arm (n=30) will receive empirically-based, Cognitive-Behavioral therapy-based strategies, tailored for transgender and gender diverse (TGD) individuals, which aims to help participants quit smoking and address gender minority stressors, anxiety, depression, and improve distress tolerance. This intervention group will likely receive 6-10 active weekly sessions, with the quit day set around session 4-6. They will also receive transdermal nicotine patches (TNP) for a period of 8 weeks prior to the quit session.

Behavioral: PRIDE QUIT

Enhanced Treatment As Usual (ETAU)

ACTIVE COMPARATOR

Participants in this arm (n=30) will receive enhanced treatment as usual at Fenway Health. These participants will attend one session (brief counseling), will come to the clinic for weekly assessments only, and receive the option of transdermal nicotine patch (TNP) and referral to the Quit Line.

Behavioral: Enhanced Treatment As Usual (ETAU)

Interventions

PRIDE QUIT BEHAVIORAL

This is an adapted behavioral intervention based on the integrated treatment for smoking cessation, anxiety, and depressed mood, known as QUIT, for persons with HIV. Through our treatment adaption process of QUIT (guided by Aim 1 and 2 data), PRIDE QUIT will be a Cognitive-Behavioral therapy-based intervention tailored for transgender and gender diverse (TGD) individuals, aimed at to helping participants quit smoking and address gender minority stressors, anxiety, depression, and improve distress tolerance. There will be three major assessments: baseline (T1), at the end of the intervention (T2), and a three-month follow-up visit (T3). This intervention group will likely receive 6-10 weekly sessions, with the quit day set around session 4-6. They will also receive transdermal nicotine patches (TNP) for a period of 8 weeks prior to the quit session.

PRIDE QUIT

Enhanced Treatment As Usual (ETAU) BEHAVIORAL

Brief counseling, the option of nicotine replacement therapy, and referral to the Quit Line.

Enhanced Treatment As Usual (ETAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18+
• self-reported difference between sex assigned at birth and gender identity
• current use of combustible cigarettes OR recent use of combustible cigarettes (defined as at least 5 cigarettes-per-day at some point within the past 6 months) OR current use of nicotine-containing e-cigarettes with use of combustible cigarettes in the past 6 months (defined as 5 cigarettes-per-day)
• English-speaking.

You may not qualify if:

• unable to provide informed consent
• current interfering untreated or unstable major health condition that is event during screening (e.g., active mania, current psychosis)

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Massachusetts General Hopsital

Boston, Massachusetts, 02114, United States

Location

Boston University - Charles River Campus

Boston, Massachusetts, 02215, United States

Location

Fenway Health

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Depression; Anxiety Disorders; Tobacco Use Disorder; Smoking; Tobacco Use; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Behavioral Symptoms; Mental Disorders; Chemically-Induced Disorders

Study Officials

• Conall M O'Cleirigh, PhD

  Massachusetts General Hospital, Behavioral Medicine Program

  PRINCIPAL INVESTIGATOR

• Amelia Stanton, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Behavioral Medicine Program/Associate Professor

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 23, 2024
• Study Start: September 1, 2024
• Primary Completion: March 18, 2025
• Study Completion: March 21, 2025
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: According to the approved DSMP, data will be uploaded at 6-monthly intervals.
• Access Criteria: Any shared data will be stored in the NIH-approved controlled access repository, Cancer Data Service (CDS). Other qualified investigators, with authorized CDS access will have access to this data.

Locations

US (3)