Actively Recruiting

Phase 2
Age: 18Years - 99Years
All Genders
NCT07040592

Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 3 Semaglutide

Led by Yale University · Updated on 2026-03-24

30

Participants Needed

1

Research Sites

75 weeks

Total Duration

On this page

Sponsors

Y

Yale University

Lead Sponsor

N

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study seeks to determine the feasibility, acceptability, and preliminary efficacy of an intervention consisting of off-label use of a medication with strong efficacy data for alcohol use disorder (AUD) with medical management and a clinical pharmacist-delivered behavioral intervention in reducing alcohol use among individuals with HIV and AUD.

CONDITIONS

Official Title

Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 3 Semaglutide

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with HIV
  • Receive care at the Atlanta VA Healthcare System
  • Aged 18 years or older
  • Meet criteria for mild, moderate, or severe alcohol use disorder by DSM-5 Alcohol Symptom Checklist and AUDIT-C screen
  • Have significant alcohol use with PEth > 20 ng/ml
  • Prescribed five or more medications
  • Have a cell phone or reliable contact number
  • Can provide written informed consent
Not Eligible

You will not qualify if you...

  • Currently engaged in formal alcohol treatment including medications for alcohol use disorder
  • Pregnant, nursing, or trying to conceive
  • Have a life-threatening or unstable medical, surgical, or psychiatric condition preventing participation
  • Untreated moderate to severe opioid use disorder
  • Live out of state
  • Unable to read or understand English
  • History of serious hypersensitivity or adverse reaction to study medication
  • Taking medications for diabetes that may interact with the study drug
  • BMI less than 23
  • Diagnosis of type 1 diabetes
  • Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2
  • Severe gastrointestinal dysmotility including gastroparesis
  • History of pancreatitis unless cause known and no longer a risk
  • Severe gallbladder disease
  • Known severe diabetic eye diseases such as proliferative diabetic retinopathy or macular edema
  • Already prescribed the study medication at recruitment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Atlanta VA Medical Center

Decatur, Georgia, United States, 30033

Actively Recruiting

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Research Team

E

E. Jennifer Edelman, MD, MHS

CONTACT

J

June-Marie Weiss, MA, MEd

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 3 Semaglutide | DecenTrialz