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NCT06654414 · ClinicalTrials.gov registry record · NA
Project QUIT+: Adapting and Testing a Smoking Cessation Intervention for Transgender and Gender Expansive Individuals
A NA study, sponsored by Massachusetts General Hospital.
- Terminated
- Registry status
- NA
- Development phase
- 3
- Enrollment target
NCT06654414: Clinical Trial NA study, sponsored by Massachusetts General Hospital.
NCT06654414 is a NA study that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 3 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06654414, a NA study, was terminated before completion, sponsored by Massachusetts General Hospital.
- TERMINATED
- Registry status
- NA
- Development phase
- 3 participants
- Enrollment target
Study 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.
Primary Outcome
Acceptability will be assessed via a questionnaire, completed after every other treatment session, that measures the 7 constructs of the acceptability of health care interventions framework: affective attitude, burden, ethicality, coherence, opportunity costs, perceived effectiveness, and self-efficacy. The intervention will be deemed acceptable if at least 75% of the participants rate 4+ items on the acceptability questionnaires with a 4 or a 5 on the Likert-style scale.
Interventions
- BEHAVIORAL Enhanced Treatment As Usual (ETAU)
- BEHAVIORAL PRIDE QUIT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2024-09-01 |
| Est. Completion | 2025-03-21 |
| Phase | NA |
Why NCT06654414 stopped before completion
NCT06654414 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Enhanced Treatment As Usual (ETAU) is the first listed.
NCT06654414 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06654414 about?
NCT06654414 is a clinical study titled "Project QUIT+: Adapting and Testing a Smoking Cessation Intervention for Transgender and Gender Expansive Individuals". 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 ...
What is the current status of trial NCT06654414?
This trial is currently terminated. It is a NA study. The enrollment target is 3 participants. The study started on 2024-09-01. Estimated completion is 2025-03-21.
What interventions are being tested in trial NCT06654414?
The interventions under investigation include: Enhanced Treatment As Usual (ETAU) (BEHAVIORAL), PRIDE QUIT (BEHAVIORAL).
Who is sponsoring clinical trial NCT06654414?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06654414's enrollment target sits among peer trials
3 1996th of 2000 higher than 4 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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