Recruiting

Adapting and Pilot Testing a Skills-based Smoking Cessation Intervention to Address Developmental and Health-related Stress Among Adults Who Smoke

ClinicalTrials.gov IDNCT06654414

PhaseNA

Enrollment100

SponsorMassachusetts General Hospital

Age18 Years and older

SexALL

I'm interested View official listing

Conditions studied

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

About this study

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.

Interventions

Behavioral: PRIDE QUIT — 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 receive a pre-randomization general educational session (session 0) followed by 5 weekly sessions and a booster sessions 4 weeks after T2, with the quit day set between sessions 3 and 4.
Behavioral: Enhanced Treatment As Usual (ETAU) — Brief counseling, American Cancer Society cessation resources (palm card with information on how to access the American Cancer Society website) after pre-randomization educational session (session 0,) the option of nicotine replacement therapy, and referral to the Quit Line.

Primary outcomes

Acceptability (Through the end of treatment intervention, approximately 6 weeks)
Feasibility of the Intervention (Through participants' enrollment, approximately 6 months)

Eligibility information

Inclusion Criteria: 1. aged 18+ 2. self-reported difference between sex assigned at birth and gender identity 3. current use of combustible cigarettes (defined as self-reported 5 combustible cigarettes per day in any week in the past month and a carbon monoxide \[CO\] expired-air reading of ≥8ppm) OR current use of nicotine-containing e-cigarettes (defined by saliva cotinine level of ≥30ng/mL) with use of combustible cigarettes (5 cigarettes per day in any week in the past month) 4. desire to stop using tobacco products (defined by ≥5 on the Motivational Aspects of Smoking Cessation Questionnaire) 5. English-speaking. Exclusion Criteria: 1. unable to provide informed consent 2. current interfering untreated or unstable major health condition (e.g., bipolar, current psychosis) 3. current use of psychotherapy for smoking cessation 4. participation in Aim 1a procedures.

Study locations

Massachusetts General Hopsital, Boston, Massachusetts 02114 United States
Boston University - Charles River Campus, Boston, Massachusetts 02215 United States
Fenway Health, Boston, Massachusetts 02215 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-13.