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New therapy aims to help transgender and nonbinary people with alcohol problems

NCT ID NCT05070793

Disease control Sponsor: New York State Psychiatric Institute 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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a specially adapted form of talk therapy for transgender and nonbinary people who have alcohol use disorder. The therapy, based on interpersonal psychotherapy, is designed to address unique life experiences that may affect drinking. The study will enroll 30 participants to see if the therapy is feasible and acceptable, and whether it reduces heavy drinking days.

What this could mean

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

Active substance
Culturally adapted interpersonal psychotherapy (talk therapy)
What this could lead to
If successful, this could provide the first evidence-based therapy for alcohol use disorder tailored to transgender and nonbinary people, potentially reducing heavy drinking in this underserved group.
What could go wrong
This is a very small, early feasibility study (30 participants) that is currently suspended. The therapy may not prove effective in larger trials, and results may not apply to all gender minority individuals.

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

30 people

The number who actually took part.

Started

Aug 2020

Expected to finish

Oct 2026

An estimate. End dates often move.

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 to 65 years

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: * 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

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Conditions

The condition(s) this trial relates to.

alcohol abuse

As listed by the trial registrant

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

Alcohol use disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • New York State Psychiatric Institute

    New York, New York, 10032, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.