Adapting a Skills-Based Smoking Cessation Program for Gender-Diverse Adults Under Stress

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project modifies an existing smoking cessation intervention to address gender minority stress and related anxiety and depression in adults who smoke. It will adapt the program PRIDE QUIT and compare it with enhanced treatment as usual in a pilot feasibility study. The study will recruit adults who identify as transgender or gender diverse, who use cigarettes or nicotine-containing products, and who want to quit, and will assess acceptability, usability, and preliminary outcomes. Feasibility metrics will include recruitment, retention, adherence, and participant feedback, along with preliminary signals of cessation success and mood changes. The work is led by Mass General Hospital with NCI collaboration and sites in Boston, MA.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fenway Health
  Boston, Massachusetts, United States Recruiting
• Massachusetts General Hopsital
  Boston, Massachusetts, United States Active not recruiting
• Boston University - Charles River Campus
  Boston, Massachusetts, United States Active not recruiting

Study contacts

• Principal investigator: Conall M O'Cleirigh, PhD — Massachusetts General Hospital, Behavioral Medicine Program
• Study coordinator: Conall M O'Cleirigh, PhD
• Email: cocleirigh@mgh.harvard.edu
• Phone: 617-643-0385

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.