Improving Alcohol Use Disorder Treatment for Gender Minority Populations

NCT05070793 | Suspended DMC

• 2 other identifiers: 79531K23AA028296
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcohol Use Disorder

Keywords

transgender; gender minority; gender identity; interpersonal; psychotherapy

Outcome Measures

Primary Outcomes (2)

• Feasibility - Completing all study sessions

  Percentage of participants who complete all intervention sessions

  9 weeks

• Acceptability - Treatment Acceptability Questionnaire

  Treatment Acceptability Questionnaire

  9 weeks

Secondary Outcomes (1)

• Heavy drinking days

  9 weeks and 13 weeks

Study Arms (1)

Culturally adapted interpersonal psychotherapy

OTHER

Individual psychotherapy intervention based on Brief Interpersonal Psychotherapy (IPT-B) with additional cultural adaptation for transgender and nonbinary individuals.

Behavioral: Culturally adapted interpersonal psychotherapy

Interventions

Culturally adapted interpersonal psychotherapy BEHAVIORAL

Individual psychotherapy based on Brief Interpersonal Psychotherapy, culturally adapted for transgender and nonbinary individuals.

Culturally adapted interpersonal psychotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

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MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Jeremy D Kidd, MD

  New York State Psychiatric Institute/Research Foundation for Mental Hygiene, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 7, 2021
• Study Start: August 1, 2020
• Primary Completion: July 31, 2025
• Study Completion (Estimated): October 31, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Starting 6 months after publication
• Access Criteria: All requests will be reviewed by the Principal Investigator. Expectation will be that requests have accompanying IRB approval for analysis of de-identified data.

Locations

US (1)