Could a diabetes drug and an addiction pill curb alcohol cravings?
NCT ID NCT07249554
First seen Jun 25, 2026 · Last updated Jul 14, 2026 · Updated 3 times
Summary
This Phase 2 trial at Johns Hopkins will test whether combining semaglutide (a GLP-1 drug used for diabetes) with naltrexone (a medication for alcohol dependence) is safe and helps reduce alcohol use. About 45 adults with alcohol use disorder will take the combination or a placebo during a 4-week inpatient program. The study focuses on safety and early signs of effectiveness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- semaglutide and naltrexone combination therapy
- What this could lead to
- If it works, this could point toward a new treatment option for alcohol use disorder that reduces cravings and drinking.
- What could go wrong
- This is a small, early Phase 2 trial with only 45 people, so results may not apply broadly. The combination may cause side effects or not work better than existing treatments.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Ashley Addiction Treatment
Havre de Grace, Maryland, 21078, United States
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