Combination Therapy for Alcohol Use Disorder

NCT07249554 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: IRB00531545
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This human laboratory study will collect preliminary safety and efficacy data from a sample of participants enrolled in a 4-week in-patient treatment program for alcohol use disorder.

Conditions

Alcohol Use Disorder

Keywords

Glucagon-like peptide 1; Naltrexone; Alcohol Use Disorder; Addiction

Outcome Measures

Primary Outcomes (1)

• Participant-reported Adverse Events

  Participant-reported adverse events during the course of the trial

  14 days

Study Arms (3)

Placebo+Placebo

PLACEBO COMPARATOR

Placebo+Placebo

Drug: Placebo

Placebo+GLP-1

EXPERIMENTAL

Placebo+GLP-1

Drug: Placebo; Drug: Glucagon-Like Peptide-1 Agonist (GLP-1)

GLP-1+Naltrexone

EXPERIMENTAL

GLP-1+Naltrexone

Drug: Glucagon-Like Peptide-1 Agonist (GLP-1); Drug: Naltrexone (oral tablets)

Interventions

Naltrexone (oral tablets) DRUG

Over-encapsulated Naltrexone (oral tablets)

GLP-1+Naltrexone

Placebo DRUG

Over-encapsulated non-active microcrystalline cellulose

Placebo+GLP-1; Placebo+Placebo

Glucagon-Like Peptide-1 Agonist (GLP-1) DRUG

Over-encapsulated Glucagon-Like Peptide-1 Agonist (GLP-1) oral tablets

GLP-1+Naltrexone; Placebo+GLP-1

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 21-65 years old
• Enrolled at Ashley Addiction Treatment center at least one week prior to beginning study participation.
• Meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for Alcohol Use Disorder
• Willing to comply with the study protocol

You may not qualify if:

• Score 9 or greater on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar) at randomization
• Currently pregnant, breastfeeding
• Unwilling to use contraceptives (e.g., condoms and/or hormonal birth control)
• Meet criteria for another substance use disorder other than AUD, Tobacco Use Disorder, or Caffeine use disorder
• History of pancreatitis
• History or current diagnosis of gallbladder disease, hepatic disease, renal disease, hyperparathyroidism, or any physical health condition that would be contraindicated with GLP-1 agonists or naltrexone.
• Unmanaged diabetes diagnosis or history or current diagnosis of diabetic retinopathy
• Levels of amylase, lipase, aspartate aminotransferase (AST), and/or alanine transferase (ALT) greater than 2x upper limit of normal
• Personal or family history of medullary thyroid carcinoma given FDA box warning for semaglutide
• Diagnosis of cancer within past 5 years
• History of multiple endocrine neoplasia syndrome type 2 (MEN2)
• Currently taking any medications contraindicated with GLP-1 agonists and/or naltrexone.
• BMI \<18.5
• Current elevated suicide risk as assessed by clinic staff or the Columbia Suicide Severity Rating Scale (C-SSRS)
• Any other medical or psychological condition that is judged by the investigators to impede ability to safely complete study requirements.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Ashley Addiction Treatment

Havre de Grace, Maryland, 21078, United States

Location

MeSH Terms

Conditions

Alcoholism; Behavior, Addictive

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Andrew S. Huhn, Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew S Huhn, Ph.D.

CONTACT

410-550-1971; ahuhn1@jhu.edu

Breanna Labos, B.A.

CONTACT

blabos1@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)