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

Who can join

Ages 18 and older · All sexes

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.

About the 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.

What is being tested

• PRIDE QUIT (behavioral)
• Enhanced Treatment As Usual (ETAU) (behavioral)

Sponsor: Massachusetts General Hospital · Participants: 100 · Started: Sep 1, 2024

Contact the study team

• Conall M O'Cleirigh, PhD · Phone: 617-643-0385
• Amelia Stanton, PhD · Phone: 617-724-6300

Official record on ClinicalTrials.gov — NCT06654414

Locations in the U.S.

Conditions

• Quitting Smoking
• Depression
• Anxiety
• Quitting Smoking (Tobacco Use Disorder)
• Smoking and Youth
• Drug Use and Addiction

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.