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Combination Therapy for Alcohol Use Disorder Phase 2 45 Combination Therapy

Not yet recruiting
Clinical Trial NCT07249554 is designed to study Treatment for Alcohol Use Disorder. This Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on May 1, 2026 until the study accrues 45 participants. Led by Johns Hopkins University, this study is expected to complete by June 1, 2028. The latest data from ClinicalTrials.gov was last updated on March 9, 2026.
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.
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 wh...Show More
Official Title

Preliminary Safety and Efficacy of Semaglutide and Naltrexone Combination Therapy for Alcohol Use Disorder

Conditions
Alcohol Use Disorder
Other Study IDs
  • IRB00531545
NCT ID Number
NCT07249554
Start Date (Actual)
2026-05
Last Update Posted
2026-03-09
Completion Date (Estimated)
2028-06
Enrollment (Estimated)
45
Study Type
Interventional
PHASE
Phase 2
Status
Not yet recruiting
Keywords
Glucagon-like peptide 1
Naltrexone
Alcohol Use Disorder
Addiction
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Placebo ComparatorPlacebo+Placebo
Placebo+Placebo
Placebo
Over-encapsulated non-active microcrystalline cellulose
ExperimentalPlacebo+GLP-1
Placebo+GLP-1
Placebo
Over-encapsulated non-active microcrystalline cellulose
Glucagon-Like Peptide-1 Agonist (GLP-1)
Over-encapsulated Glucagon-Like Peptide-1 Agonist (GLP-1) oral tablets
ExperimentalGLP-1+Naltrexone
GLP-1+Naltrexone
Glucagon-Like Peptide-1 Agonist (GLP-1)
Over-encapsulated Glucagon-Like Peptide-1 Agonist (GLP-1) oral tablets
Naltrexone (oral tablets)
Over-encapsulated Naltrexone (oral tablets)
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Participant-reported Adverse Events
Participant-reported adverse events during the course of the trial
14 days
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
21 Years
Eligible Sexes
All
  • 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

  • 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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Study Central Contact
Contact: Andrew S Huhn, Ph.D., 410-550-1971, [email protected]
Contact: Breanna Labos, B.A., [email protected]
1 Study Locations in 1 Countries

Maryland

Ashley Addiction Treatment, Havre de Grace, Maryland, 21078, United States
Andrew S Huhn, Ph.D., Contact, 410-550-1971, [email protected]