What this study is
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.
What's being tested
- Placebo
Intervention · DRUG
Over-encapsulated non-active microcrystalline cellulose
- Glucagon-Like Peptide-1 Agonist (GLP-1)
Intervention · DRUG
Over-encapsulated Glucagon-Like Peptide-1 Agonist (GLP-1) oral tablets
- Naltrexone (oral tablets)
Intervention · DRUG
Over-encapsulated Naltrexone (oral tablets)
Study details
- Official title
- Preliminary Safety and Efficacy of Semaglutide and Naltrexone Combination Therapy for Alcohol Use Disorder
- Sponsor
- Johns Hopkins University
- Conditions
- Alcohol Use Disorder
- Enrolling
- 45 people
- Starts
- 2026-11
- Est. completion
- 2028-09
- Design
- Quadruple-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 21 Years – 65 YearsSex ALLHealthy volunteers Not acceptedYou 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 can't join 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.
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openAshley Addiction Treatment
Havre de Grace, Maryland, United States
- Andrew S Huhn, Ph.D. · Contact410-550-1971ahuhn1@jhu.edu
Study team
Sponsor
Johns Hopkins University
Study ID IRB00531545
Principal investigator
Andrew S. Huhn, Ph.D.
Johns Hopkins University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.