Health TrialsbyHealthPanel

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

ConditionsAlcohol Use Disorder (AUD)HIV
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-99
SponsorYale University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • semaglutide

    Drug

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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: SemaglutideExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Time frame
12 weeks
2

Number of sessions completed

Number of sessions completed to assess acceptability of study

Time frame
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

Time frame
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.

Time frame
12 weeks

Secondary outcomes

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.

Time frame
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.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Source ClinicalTrials.gov
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