SuspendedNot Applicable

Improving Alcohol Use Disorder Treatment for Gender Minority Populations

Stopped: Institutional Research Pause

United States30 participantsStarted 2020-08-01

Plain-language summary

Gender minority (GM; transgender and gender non-conforming) individuals experience disproportionately high rates of hazardous drinking and alcohol use disorder (AUD) and are an NIH-designated disparity population (NOT-MD-19-001). Despite marked disparities and unique alcohol risk factors, there are no evidence-based alcohol interventions for this population. This study will conduct mixed-methods formative research with an established multi-site longitudinal GM cohort to develop and assess the feasibility of the first culturally-adapted psychosocial treatment intervention for GMs with AUD. The study will evaluate an adapted version of interpersonal psychotherapy (IPT), with adaptations intended to enhance the responsiveness of IPT to the unique life experiences of GM individuals that may influence alcohol consumption.

Who can participate

Age range

18 Years – 65 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: * GM self-identification * English fluency, * Current DSM-5 Alcohol use disorder (AUD) (moderate-to-severe) * AUD treatment-seeking * Able to give informed consent and comply with study procedures Exclusion Criteria: * Severe psychiatric symptoms that would interfere with treatment (e.g., psychosis, active suicidality) * History of severe alcohol withdrawal (e.g., seizure, delirium tremens) * Legally mandated to treatment * Current DSM-5 SUD other than alcohol/nicotine/caffeine/cannabis

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

Feasibility - Completing all study sessions

Timeframe: 9 weeks

Acceptability - Treatment Acceptability Questionnaire

Timeframe: 9 weeks

Trial details

NCT IDNCT05070793

SponsorNew York State Psychiatric Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-31

View on ClinicalTrials.gov More Alcohol Use Disorder trials