Recruiting

Smoking Cessation

Sponsor:

Massachusetts General Hospital

Code:

NCT06654414

Conditions

Smoking Cessation

Depression

Anxiety

Nicotine Dependence

Gender Minority Stress

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PRIDE QUIT

Enhanced Treatment As Usual (ETAU)

Study Details

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

Study ID

NCT06654414

Start date

Sep 1, 2024

Status verified date

Oct, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PRIDE QUIT

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 receive a general educational session (session 0) followed by 5 active weekly sessions and a booster session 4 weeks after T2 (approx. 14 weeks post-baseline), with the quit day set between sessions 3 and 4.

active comparator: Enhanced Treatment As Usual (ETAU)

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 referral to the Quit Line.

Interventions

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.

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 outcome measure

  • Acceptability [ Time Frame: Through the end of treatment intervention, approximately 6 weeks ]
  • Feasibility of the Intervention [ Time Frame: Through participants' enrollment, approximately 6 months ]

Central Contacts and Locations

Central contacts

Conall M O'Cleirigh, PhD

617-643-0385cocleirigh@mgh.harvard.edu

Amelia Stanton, PhD

617-724-6300stantona@bu.edu

Locations

Fenway Health

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Elizabeth Loynd

617-927-6216eloynd@fenwayhealth.org

Elliott Weinstein, PhD

ERWEINSTEIN@mgh.harvard.edu

Principal Investigator:

Amelia Stanton, PhD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Oct 8, 2026

Last verified

Oct, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-10-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.