Alcohol Use DisorderPhase 2NCT07249554
Combination Therapy for Alcohol Use Disorder
A Phase 2 study testing Glucagon-Like Peptide-1 Agonist (GLP-1) and Naltrexone (oral tablets) in people with Alcohol Use Disorder, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Glucagon-Like Peptide-1 Agonist (GLP-1) and Naltrexone (oral tablets)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Breanna Labos, B.A. contact
United States1 site
Ashley Addiction Treatment
Havre de Grace, Maryland, 21078
Andrew S Huhn, Ph.D., 410-550-1971, ahuhn1@jhu.edu
About this study
Official title: Preliminary Safety and Efficacy of Semaglutide and Naltrexone Combination Therapy for Alcohol Use Disorder
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.
Read the detailed description
Approximately 29 million persons in the United States aged 12 and older experienced a form of Alcohol Use Disorder (AUD) in 2023. Currently, only three pharmacotherapies are FDA-approved to treat AUD: acamprosate, naltrexone, and disulfiram. As monotherapies, these have shown moderate efficacy in reducing alcohol consumption and increasing abstinence. There is some evidence that therapeutic effects can be enhanced when combined with other medications. Recently, emerging preclinical evidence suggests that endogenous GLP-1 signaling plays a role in alcohol-mediated behaviors. Further, growing clinical data suggest that GLP-1 agonists (e.g., Wegovy, Rybelsus, Mounjaro) may be effective for the treatment of AUD. Studies evaluating the efficacy of GLP-1 agonists in combination with FDA-approved medications for AUD have yet to be conducted. The investigators hypothesize that combining a GLP-1 agonist and naltrexone may be more effective for reducing dimensions of AUD than naltrexone alone. The goal of this study is to collect preliminary safety and efficacy data from a sample of participants enrolled in a 4-week in-patient treatment program for AUD. Following one week of in-patient enrollment, participants will be randomized to one of three conditions in a double dummy design: placebo + placebo, GLP-1 + placebo, or GLP-1 + naltrexone. All study medications will be administered orally. Participants randomized to active GLP-1 conditions will receive 3 mg during study week 1 and can increase to 7 mg during week 2. Participants will attend study visits in a 14-day period to complete assessments of alcohol craving, alcohol demand, anhedonia, eating behaviors, and subjective effects. Participants will also provide vitals and biosamples to evaluate health outcomes.
- Conditions
- Alcohol Use Disorder
- Being tested
- Placebo, Glucagon-Like Peptide-1 Agonist (GLP-1), Naltrexone (oral tablets)
- Keywords
- Glucagon-like peptide 1, Naltrexone, Alcohol Use Disorder, Addiction
- Medical subject headings
- Alcoholism, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Over-encapsulated non-active microcrystalline cellulose
Glucagon-Like Peptide-1 Agonist (GLP-1)Drug
Over-encapsulated Glucagon-Like Peptide-1 Agonist (GLP-1) oral tablets
Naltrexone (oral tablets)Drug
Over-encapsulated Naltrexone (oral tablets)
| Study group | Role | What they receive |
|---|---|---|
| Placebo+Placebo | Placebo comparator | Placebo+Placebo Receives: Drug: Placebo |
| Placebo+GLP-1 | Experimental | Placebo+GLP-1 Receives: Drug: Placebo; Drug: Glucagon-Like Peptide-1 Agonist (GLP-1) |
| GLP-1+Naltrexone | Experimental | GLP-1+Naltrexone Receives: Drug: Glucagon-Like Peptide-1 Agonist (GLP-1); Drug: Naltrexone (oral tablets) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant-reported Adverse Events
Participant-reported adverse events during the course of the trial
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study startNov 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew S. Huhn, Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07249554
- Sponsor's protocol ID
- IRB00531545
- Status last verified
- Sep 2026
- First submitted
- 18 Nov 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data may be shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Safety and Efficacy of Semaglutide and Naltrexone Combination Therapy for Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT07249554
- Acronym / sponsor ID
- IRB00531545
- Conditions
- Alcohol Use Disorder
- Keywords
- Glucagon-like peptide 1, Naltrexone, Alcohol Use Disorder, Addiction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Approximately 29 million persons in the United States aged 12 and older experienced a form of Alcohol Use Disorder (AUD) in 2023. Currently, only three pharmacotherapies are FDA-approved to treat AUD: acamprosate, naltrexone, and disulfiram. As monotherapies, these have shown moderate efficacy in reducing alcohol consumption and increasing abstinence. There is some evidence that therapeutic effects can be enhanced when combined with other medications. Recently, emerging preclinical evidence suggests that endogenous GLP-1 signaling plays a role in alcohol-mediated behaviors. Further, growing clinical data suggest that GLP-1 agonists (e.g., Wegovy, Rybelsus, Mounjaro) may be effective for the treatment of AUD. Studies evaluating the efficacy of GLP-1 agonists in combination with FDA-approved medications for AUD have yet to be conducted. The investigators hypothesize that combining a GLP-1 agonist and naltrexone may be more effective for reducing dimensions of AUD than naltrexone alone. The goal of this study is to collect preliminary safety and efficacy data from a sample of participants enrolled in a 4-week in-patient treatment program for AUD. Following one week of in-patient enrollment, participants will be randomized to one of three conditions in a double dummy design: placebo + placebo, GLP-1 + placebo, or GLP-1 + naltrexone. All study medications will be administered orally. Participants randomized to active GLP-1 conditions will receive 3 mg during study week 1 and can increase to 7 mg during week 2. Participants will attend study visits in a 14-day period to complete assessments of alcohol craving, alcohol demand, anhedonia, eating behaviors, and subjective effects. Participants will also provide vitals and biosamples to evaluate health outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo+Placebo | Placebo comparator | Drug: PlaceboPlacebo+Placebo |
| Placebo+GLP-1 | Experimental | Drug: Placebo, Drug: Glucagon-Like Peptide-1 Agonist (GLP-1)Placebo+GLP-1 |
| GLP-1+Naltrexone | Experimental | Drug: Glucagon-Like Peptide-1 Agonist (GLP-1), Drug: Naltrexone (oral tablets)GLP-1+Naltrexone |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboOver-encapsulated non-active microcrystalline cellulose | Drug | Placebo+GLP-1, Placebo+Placebo |
| Glucagon-Like Peptide-1 Agonist (GLP-1)Over-encapsulated Glucagon-Like Peptide-1 Agonist (GLP-1) oral tablets | Drug | GLP-1+Naltrexone, Placebo+GLP-1 |
| Naltrexone (oral tablets)Over-encapsulated Naltrexone (oral tablets) | Drug | GLP-1+Naltrexone |
Primary outcome
Participant-reported Adverse Events
Time frame: 14 days
Participant-reported adverse events during the course of the trial
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No. Data may be shared upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Breanna Labos, B.A. contact
Andrew S. Huhn, Ph.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Glucagon-Like Peptide-1 Agonist (GLP-1) and Naltrexone (oral tablets) in people with Alcohol Use Disorder, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew S Huhn, Ph.D. (410-550-1971, ahuhn1@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant-reported Adverse Events (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.