Combination Therapy for Alcohol Use Disorder

This study is looking at new ways to treat Alcohol Use Disorder (AUD). Researchers are testing if combining a Glucagon-Like Peptide-1 Agonist (GLP-1) with naltrexone might work better than naltrexone alone. Naltrexone is an FDA-approved medication for AUD. The study will also look at a placebo (an inactive pill) to compare results. To join, you must be between 21 and 65 years old, have an AUD diagnosis, and be enrolled at Ashley Addiction Treatment center for at least one week before starting the study. The main goal is to see how many participants report side effects after 14 days. The study is currently unclear about its status and plans to enroll 45 participants.

Study design: This study is an interventional study, meaning participants will receive specific treatments. It plans to enroll 45 participants and uses a "double dummy" design, where neither you nor the study staff will know which treatment you are receiving.
What's involved: Participants will be enrolled in a 4-week inpatient treatment program for alcohol use disorder. Following one week of inpatient enrollment, you will be randomized to one of three treatment groups.
Compensation: Not stated in the trial record.
Follow-up: The primary endpoint, participant-reported adverse events, is measured at 14 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Combination Therapy for Alcohol Use Disorder

Not Yet Recruiting

PHASE2Ages 21–65InterventionalTreatment

Johns Hopkins University

~45 participants

Updated 2026-07-13 on ClinicalTrials.gov

What's tested:PlaceboGlucagon-Like Peptide-1 Agonist (GLP-1)Naltrexone (oral tablets)

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Participant-reported Adverse Events

Measured over 14 days

Conditions

Alcohol Use Disorder

Where it's being run

1 sites across 1 states

Maryland1

Study leadership

Andrew S. Huhn, Ph.D. · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Andrew S Huhn, Ph.D.

[email protected]

410-550-1971

Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

Exclusion

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.

Legal problems or living situation judged by the investigators as a factor that could interfere with study completion (e.g., impending jail time).

Allergies to semaglutide and/or naltrexone

Use of opioids within the past 10 days as indicated by self-report or a positive urine drug screen

Prescribed or taking the following medications in the past four weeks:

The following medications will be prohibited during study participation due to interactions with semaglutide: other GLP-1 agonists (e.g. Exenatide, liraglutide, dulaglutide), insulin, insulin-secreting medications (e.g. sulfonylureas, meglitinides), tirzepetide, dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g. sitagliptin, saxagliptin, linagliptin, alogliptin, evogliptin, and gemigliptin).

The following medications will be prohibited during study participation due to interactions with naltrexone: bremelanotide, peripherally-acting mu-opioid receptor antagonists (e.g. methylnaltrexone, naldemedine), and opioid agonist medications.

What this trial measures

Participant-reported Adverse Events14 days
Participant-reported adverse events during the course of the trial

Trialytics