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Alcohol Use Disorder (AUD)Phase 2HARPNCT07040592

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

A Phase 2 study testing semaglutide in people with Alcohol Use Disorder (AUD) and HIV, run by Yale University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Alcohol Use Disorder (AUD), HIV
What is being tested?
semaglutide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
15 Jan 2026to 30 Jun 2027
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 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • diagnosed with HIV
  • Receive care at the Atlanta VA Healthcare System
  • Age 18 or over
  • Meet criteria for mild, moderate, or severe alcohol use disorder by the DSM-5 Alcohol Symptom Checklist and the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) screen
  • Have evidence of significant alcohol use: PEth > 20ng/ml
  • Prescribed >=5 medications
  • Have cell phone or reliable contact number
  • Can provide written informed consent

Who cannot join

  • Active engagement in formal alcohol treatment including medications for alcohol use disorder at the time of enrollment
  • Self-report or laboratory test confirming pregnancy, nursing, or trying to conceive
  • Life-threatening or unstable medical, surgical, or psychiatric condition that prohibits participation (including current or past intent to harm oneself or others within the prior 12 months and not receiving treatment)
  • Untreated moderate to severe opioid use disorder
  • Residence out of state
  • Inability to read or understand English
Show all 13Show fewer
  • History of serious hypersensitivity or adverse reaction to study medication
  • Taking potentially interactive medication(s) for diabetes
  • BMI<23
  • Diagnosis of type 1 Diabetes
  • Personal or family history of medullary thyroid carcinoma, Multiple Endocrine Neoplasia syndrome type 2, Severe gastrointestinal dysmotility, including gastroparesis, History of pancreatitis (does not pertain to patients for whom the cause of pancreatitis is known and no longer presents a risk), severe gallbladder disease
  • Known Proliferative Diabetic Retinopathy, severe Non-Proliferative Diabetic Retinopathy, clinically significant Macular Edema, or Cystoid Macular Edema
  • Already prescribed the pilot medication at the time of study recruitment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

E. Jennifer Edelman, MD, MHS contact

203-737-7115

ejennifer.edelman@yale.edu

June-Marie Weiss, MA, MEd contact

203-737-3347

junemarie.weiss@yale.edu

United States1 site, 1 recruiting

  • Atlanta VA Medical Center

    Decatur, Georgia, 30033

    Ketteria Ingram, 407-914-6083, Ketteria.Ingram@va.gov

    Vincent Marconi, MD

    Recruiting

Other trials in United States

About this study

Official title: Feasibility, Acceptability, and Preliminary Efficacy of Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: An Open-Label Pilot Study

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.

Read the detailed description

This is a series of three open-label pilot studies that consist of a 12-week intervention including off-label use of medication with MM and a clinical pharmacist-delivered behavioral intervention to treat AUD. Participants will receive counseling that incorporates brief feedback and advice with motivational enhancement techniques to assist the participant in changing their behaviors with respect to alcohol consumption and/or polypharmacy defined as taking five or more medications, particularly if those medications interact with alcohol.

In addition, participants will be offered semaglutide in the third pilot study. The rationale for utilizing an open-label pilot study design is to determine the feasibility, acceptability, safety, and preliminary efficacy of this intervention for the management of AUD. Participants will be interviewed with regards to their perspectives on feasibility and acceptability. They will be instructed to have medication bottles at study visits to assess medication adherence and will be assessed with readiness to change metrics and questions regarding quantity and frequency of alcohol use. Patients will also be asked to complete an AUDIT-C screen and the Alcohol Symptom Checklist at the start of the study period to screen for mild, moderate, or severe AUD. Several assessments including interviews and laboratory testing will be done at study visits.

Being tested
semaglutide
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • semaglutideDrug

    All participants will receive a prescription for semaglutide and will meet with a clinical pharmacist and addiction psychiatrist for further support

Study groups in NCT07040592
Study groupRoleWhat they receive
SemaglutideExperimentalParticipants will receive a prescription for semaglutide.
Receives: Drug: semaglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants who complete enrollment and duration of sessions

    Proportion of participants who complete enrollment and duration of sessions to assess feasibility of study

    Measured: 12 weeks

  2. Number of sessions completed

    Number of sessions completed to assess acceptability of study

    Measured: 12 weeks

  3. Adherence to Medication

    Medication adherence will be measured by the number of prescriptions filled by electronic health record to assess acceptability of study

    Measured: 12 weeks

  4. Safety of study assessed by adverse event reporting

    Safety will be assessed by the percentage of study participants who report adverse events.

    Measured: 12 weeks

Secondary outcomes (2)

  1. Efficacy of study - change in self-reported alcohol use

    Change in self-reported alcohol use (# of days of alcohol use and # of drinks per day) on the Timeline Followback.

    Measured: 12 weeks

  2. Efficacy of study - change in PEth (phosphatidylethanol) results

    PEth is a biomarker for alcohol consumption. Change in PEth result from baseline PEth levels.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2025
  2. Study start15 Jan 2026
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07040592
Sponsor's protocol ID
2000033919_c
Other IDs
1P01AA029545-01
Acronym
HARP
Status last verified
Mar 2026
First submitted
12 Jun 2025
Last updated
24 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing semaglutide in people with Alcohol Use Disorder (AUD) and HIV, run by Yale 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 8 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 24 Mar 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. 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 E. Jennifer Edelman, MD, MHS (203-737-7115, ejennifer.edelman@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants who complete enrollment and duration of sessions (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07040592.

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 24 Mar 2026.

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