Project QUIT+: Adapting and Testing a Smoking Cessation Intervention for Transgender and Gender E… (NCT06654414) | Clinical Trial Compass
TerminatedNot Applicable
Project QUIT+: Adapting and Testing a Smoking Cessation Intervention for Transgender and Gender Expansive Individuals
Stopped: The study was terminated prematurely by NIH action with the stated reason that the goals of the study no longer effectuate NIH priorities.
United States3 participantsStarted 2024-09-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Acceptability
Timeframe: Through the end of treatment intervention, approximately 10 weeks
2
Feasibility
Timeframe: Through participants' enrollment, approximately 6 months