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Project QUIT+: adapting and testing a smoking cessation intervention for transgender and gender expansive individuals

NCT ID NCT06654414

NEW Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

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Recruiting now
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Not yet recruiting
Registered, but not yet taking participants.
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Paused for now. It may or may not start again.
Ongoing
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Completed
The trial has finished. Results may not be published yet.
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Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Approved
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When the status isn't known

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First seen Sep 09, 2026 · Last updated Sep 09, 2026

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.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

3 people

The number who actually took part.

Started

Sep 2024

Finished

Mar 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * aged 18+ * self-reported difference between sex assigned at birth and gender identity * current use of combustible cigarettes OR recent use of combustible cigarettes (defined as at least 5 cigarettes-per-day at some point within the past 6 months) OR current use of nicotine-containing e-cigarettes with use of combustible cigarettes in the past 6 months (defined as 5 cigarettes-per-day) * English-speaking. Exclusion Criteria: * unable to provide informed consent * current interfering untreated or unstable major health condition that is event during screening (e.g., active mania, current psychosis)

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Conditions

The condition(s) this trial relates to.

anxiety anxiety disorder Depression depressive disorder nicotine dependence Smoking Smoking Cessation substance-related disorder Tobacco Use

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anxiety Depression Gender minority stress Nicotine dependence Smoking cessation

Contacts and locations

Locations

  • Boston University - Charles River Campus

    Boston, Massachusetts, 02215, United States

  • Fenway Health

    Boston, Massachusetts, 02215, United States

  • Massachusetts General Hopsital

    Boston, Massachusetts, 02114, United States

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