🏛️ Verified NIH Record • Updated 2026-07-10

Combination Therapy for Alcohol Use Disorder (NCT07249554)

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

🟡 Not Yet Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Johns Hopkins University

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (22 items).

Location: Ashley Addiction Treatment — Havre de Grace, Maryland

Age range: 21 Years to 65 Years

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • 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)

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • Ashley Addiction Treatment — Havre de Grace, Maryland

📞 Contact the Study Coordinator

Phone: (410) 550-1971

Email: ahuhn1@jhu.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗