Adapting and Pilot Testing a Skills-based Smoking Cessation Intervention to Address Developmental and Health-related Stress Among Adults Who Smoke
Key facts
- Who runs it
- Massachusetts General Hospital
- Where
- Boston, United StatesSee the 3 sites
- Trial code
- Status
- Recruiting
- People taking part
- 100 people, planned
- Started
- 1 Sept 2024
- Expected to end
- 31 Aug 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- PRIDE QUIT
- Enhanced Treatment As Usual (ETAU)
- Record updated
- 8 October 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- aged 18+
- self-reported difference between sex assigned at birth and gender identity
- 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)
- desire to stop using tobacco products (defined by ≥5 on the Motivational Aspects of Smoking Cessation Questionnaire)
- English-speaking
Who cannot take part
- current interfering untreated or unstable major health condition (e.g., bipolar, current psychosis)
- unable to provide informed consent
- current use of psychotherapy for smoking cessation
- participation in Aim 1a procedures
Where in United States
- Fenway HealthBoston, United StatesContact: Elizabeth LoyndTaking people
- Boston University (Charles River Campus)Boston, United StatesContact: Conall M O'Cleirigh, PhDNo longer taking part
- Massachusetts General HopsitalBoston, United StatesContact: Conall M O'Cleirigh, PhDNo longer taking part
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- PRIDE QUITTreatment being tested
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.
- Enhanced Treatment As Usual (ETAU)Existing treatment, for comparison
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 8 October 2026