Improving Alcohol Use Disorder Treatment for Gender Minority Populations

April 23, 2026 updated by: New York State Psychiatric Institute
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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND

Transgender and nonbinary individuals (TGNB; i.e., gender minorities) have a gender identity and/or gender expression that differs from the female or male sex that they were assigned at birth. This difference (gender incongruence) can cause psychological distress. Comprising roughly 0.5% of the U.S. population, TGNB people bear numerous health disparities including hazardous drinking (HD; binge drinking and/or heavy drinking) and alcohol use disorder (AUD). These relate to stigma and discrimination. Numerous studies have found high rates of past 30-day drinking (21-58%), binge drinking (21-51%), and heavy drinking (26%). These rates exceed general population estimates of past 30-day binge drinking (16.3%) and heavy drinking (5.9%).

TGNB people suffer interpersonal disruptions that serve as culturally-distinct alcohol risk factors. Such interpersonal disruptions are related to HD via increased interpersonal distress. TGNB people have interpersonal distress in unique contexts such as gender transition and anti-TGNB discrimination/stigma. Gender transition is the process of reducing gender incongruence through aesthetics (e.g., clothing), hormones (e.g., estrogen/testosterone), and/or surgery (e.g., vaginoplasty/phalloplasty). This often brings changes in key interpersonal relationships, varying from renegotiation (e.g., a heterosexual couple adjusting to being a same-gender couple after one partner transitions) to dissolution (e.g., divorce). TGNB people also experience high rates of discrimination (distal minority stress) that affect relationships (e.g., a biased employer). In both contexts, interpersonal disruptions and distress increase alcohol risk, possibly via diminished social support. Many TGNB adults report drinking to cope with interpersonal stressors. Conversely, TGNB peer support protects against such distress and HD.

Culturally-adapted treatment may benefit interpersonal disruptions and distress occurring in the context of discrimination. Of TGNB adults, 24% reported having to teach their healthcare providers about TGNB experiences. Studies of addiction treatment staff found that most knew little about TGNB issues and nearly half held negative or ambivalent views about TGNB patients. Qualitative studies of TGNB individuals in addiction treatment found stigmatization was common, including prohibitions on disclosing TGNB identity or being forced to wear clothing inconsistent with gender identity. This can lead to treatment avoidance or termination.

Cultural-adaptation considers "language, culture, and context" to increase treatment compatibility with patients' cultural norms/values. Among various cultural adaptation models, the Cultural Sensitivity Framework (CSF) was specifically designed for addiction research. In CSF, adaptation addresses both surface (concrete) and deep (abstract) structures. In racial/ethnic and sexual minority (lesbian/gay/bisexual) studies, cultural adaptation improved treatment acceptability, retention, and effectiveness; including for addiction. Aside from conceptual discussions, there are no culturally-adapted TGNB AUD interventions.

Separate evidence-based approaches exist for interpersonal distress (e.g., IPT) and alcohol (e.g., motivation interviewing; MI), but there are no integrated treatments for both that target the interpersonal contexts TGNB people face. IPT, a time-limited manualized psychotherapy, identifies an interpersonal problem area (grief, role disputes, role transitions, interpersonal deficits) and reduces symptoms by enhancing interpersonal coping and social support. IPT's focus on "role transition" and "role disputes" especially applies to gender transition-related interpersonal disruptions and distress. Over 133 clinical trials have validated IPT for depression and for PTSD-common co-morbidities for TGNB individuals. IPT AUD research is limited. Extant research on co-morbid depression and AUD is equivocal, but these studies were designed with depression as the primary outcome and enrolled mostly non-TGNB patients with low-level drinking. Researchers have called for studies of IPT with MI strategies for AUD in populations with salient interpersonal risk factors (i.e., TGNB populations).

STUDY PROCEDURES

Overall strategy: This pilot trial of culturally-adapted Brief Interpersonal Psychotherapy (IPT-B) for transgender and nonbinary (TGNB) individuals with AUD utilizes a single-arm, pre-post, convergent mixed methods design to explore whether and how the intervention engages interpersonal targets. This design enables the investigators to link qualitative themes regarding individuals' experiences of the intervention with quantitative measures of interpersonal targets. The investigators will also evaluate the feasibility of research and intervention procedures and the acceptability of the information and support provided by the therapist.

Participants: TGNB individuals with alcohol use disorder (AUD) (N = 20). We anticipate enrolling 50% individuals assigned female at birth and at least 30% non-White individuals.

Screening: Interested individuals will be complete a standardized telephone interview and will be invited to participate if they meet eligibility criteria for an evaluation. This subsequent evaluation will include the MINI International Neuropsychiatric Interview(57) to assess current and lifetime DSM-5 diagnoses, a psychiatric and medical evaluation (including urine drug screen). Eligible individuals will be invited to enroll in the trial and will provide written informed consent. Individuals will be compensated for this screening evaluation.

Assessment Schedule: After baseline assessment, there will be 9 weekly intervention visits plus 1-month follow-up. The intervention will be delivered by trained clinical staff. At intervention completion, participants will be provided with referrals for continued outpatient treatment and a list of Alcoholics Anonymous meetings. Study staff will administer outcomes measures without participating in intervention delivery. This will include administering alcohol and interpersonal target measures at Baseline, Weeks 5 and 9, and 1-month follow-up. At intervention completion (Week 9), study staff will administer acceptability measures; including qualitative assessment of treatment acceptability, interpersonal targets, and drinking. Participants will be compensated for completing study assessments. Psychotherapy will not be compensated. For safety, study staff will obtain vital signs and a breathalyzer before each visit; and will assess alcohol withdrawal and overall symptom severity at each visit. Staff will also assess for suicide risk and psychiatric symptoms at Baseline, Weeks 5 and 9, and 1-month follow-up.

Measures:

Feasibility: Staff will track data pertaining to recruitment, retention, and assessment procedures following CONSORT guidelines; including the duration and number of intervention contacts per participant.

Acceptability: After each session, therapists and participants will complete the Working Alliance Inventory-Short Form (WAI-SF) to assess their perception of the therapeutic alliance. Staff will use the Treatment Acceptability Questionnaire (TAQ) to assess participants' perceptions of the intervention's clarity/helpfulness/appropriateness/relevance and the therapist's skill and trustworthiness. This will include open-ended, qualitative questions about participants' experiences of the intervention (e.g., culturally-tailored elements); including perceived strengths and weaknesses, session length/content, therapeutic alliance, value of TGNB cultural adaptations, and recommendations for improvement.

Fidelity: Staff will audio record all intervention sessions. Sessions will be randomly chosen and reviewed by the Principal Investigator and an IPT research expert. Sessions will be scored using the Collaborative Study Psychotherapy Rating Scale-Form 6.

Demographics: Staff will collect information about age, race/ethnicity, assigned sex, education, and annual household income. Staff will also assess current/lifetime gender-affirming hormone use and surgeries.

Discrimination and Stigma: For descriptive purposes, staff will assess experiences of discrimination with the Everyday Discrimination Scale and stigma with the Stigma Consciousness Questionnaire.

Alcohol Consumption: The Timeline Followback (TLFB; 28-day at baseline; 7-day thereafter) to assess drinking and urine ethyl glucuronide (EtG), a metabolite of alcohol metabolism, as a biomarker of recent (~past 24-hour) drinking.

Alcohol Motivation/Expectancy: Readiness to Change Questionnaire-Treatment Version (RCQ-TV) to measure motivation to reduce drinking, Coping Strategies Scale (CSS) for coping ability with alcohol cravings, Alcohol Abstinence Self-Efficacy Scale (AASE) to measure participants' perceived ability to reduce drinking, Alcohol Expectancy Questionnaire (AEQ) to assess anticipated positive alcohol experiences, and Drinker Inventory of Consequences (DrInC) to measure negative alcohol consequences.

Interpersonal Targets: The Multidimensional Scale of Perceived Social Support (MSPSS) for family/friend support, an adapted scale from AFFIRM for GM peer support, the Social Adjustment Scale-Self Report (SAS-SR) to assess satisfaction with social supports, and the Inventory of Interpersonal Problems (IIP) to assess interpersonal disruptions/distress. Staff will use the Reflective Functioning Questionnaire (RFQ) to measure mentalization (ability to understand mental states of oneself and others). Increased mentalization capacity may be one mechanism by which IPT reduces interpersonal distress and psychiatric symptoms.

Co-morbidities: The Hamilton Depression Rating Scale (HAM-D) and PTSD Checklist (PCL-5) will assess these symptom domains. I will assess concurrent drug use with the Timeline Followback (28-day at baseline; 7-day thereafter) and urine qualitative drug screens.

Safety: Breathalyzer to assess alcohol intoxication, the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar) to evaluate alcohol withdrawal, the Columbia Suicide Severity Rating Scale (CSSRS) for suicide risk, and the Clinical Global Impressions Scale for severity (CGI-S) and improvement (CGI-I).

Data analysis: This trial's purpose is to collect preliminary data about feasibility and engagement of interpersonal targets.

Missed Visits/Drop-Out: These rates are reported directly as part of the primary feasibility outcome.

Hypotheses: At least 75% of participants will complete the intervention (feasibility); At least 80% will report treatment satisfaction (acceptability).

Primary Analysis: Primary outcomes will be treatment feasibility (% completion) and acceptability (Treatment Acceptability Questionnaire). We will report quantitative data using descriptive statistics. For qualitative data, interviews will be audio recorded and professionally transcribed. Next, transcripts will be iteratively coded, identifying codes and categories (codebook) that we will apply to the entire data set. To ensure consistency, we will double-code 10% of interviews.

Exploratory outcomes: While this study does not have statistical power to test formal hypotheses regarding alcohol outcomes or interpersonal targets, we will examine % reduction in heavy drinking days (≥5 drinks for GM women; ≥4 for GM men) and % days abstinent as well as alcohol motivation/expectancy and interpersonal target variables. WE will measure pre-post change and report these using descriptive statistics.

Dr Jeremy Kidd's last day at Columbia University/New York State Psychiatric Institute was 07/31/2025, and is on faculty at Mount Sinai Icahn School of Medicine.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Culturally adapted interpersonal psychotherapy
Individual psychotherapy intervention based on Brief Interpersonal Psychotherapy (IPT-B) with additional cultural adaptation for transgender and nonbinary individuals.
Behavioral: Culturally adapted interpersonal psychotherapy
Individual psychotherapy based on Brief Interpersonal Psychotherapy, culturally adapted for transgender and nonbinary individuals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility - Completing all study sessions
Time Frame: 9 weeks
Percentage of participants who complete all intervention sessions
9 weeks
Acceptability - Treatment Acceptability Questionnaire
Time Frame: 9 weeks
Treatment Acceptability Questionnaire
9 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heavy drinking days
Time Frame: 9 weeks and 13 weeks
Percent reduction in heavy drinking days (≥5 drinks for GM women; ≥4 for GM men)
9 weeks and 13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Jeremy D Kidd, MD, New York State Psychiatric Institute/Research Foundation for Mental Hygiene, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2020

Primary Completion (Actual)

July 31, 2025

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

September 27, 2021

First Submitted That Met QC Criteria

September 27, 2021

First Posted (Actual)

October 7, 2021

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7953
  • 1K23AA028296 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will share all IPD that underlie results in publications related the primary and secondary hypotheses of the trial.

IPD Sharing Time Frame

Starting 6 months after publication

IPD Sharing 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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