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Can a Quit-Smoking program built for transgender adults help them stop?

NCT ID NCT06654414

Symptom relief Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time

Summary

Transgender and gender diverse adults smoke at higher rates than the general population, and stigma, discrimination, anxiety, and depression may make quitting harder. Researchers at Massachusetts General Hospital are adapting an existing smoking cessation program called QUIT, which was designed for people with HIV, into a new version called PRIDE QUIT. The adapted program uses cognitive behavioral therapy to help participants quit smoking while also addressing gender minority stress, anxiety, and depression. A small pilot study will test whether the program is practical to deliver and acceptable to participants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PRIDE QUIT, a cognitive behavioral therapy program tailored for transgender and gender diverse people that combines smoking cessation with support for gender minority stress, anxiety, and depression
What this could lead to
If it works, this could give transgender and gender diverse adults a quit-smoking program that also addresses the stigma, anxiety, and depression that make quitting harder.
What could go wrong
This is a tiny pilot with only 3 participants, so it can only show whether the program is practical and acceptable, not whether it helps people quit. The approach may not fit everyone, and larger studies would be needed to know if it works.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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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