RECRUITING

Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 2

Description

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

Alcohol Use DisorderHivTobacco Use Disorder
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Related Conditions:

Alcohol Use DisorderHivTobacco Use Disorder

Study Overview

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Study Details

Study overview

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.

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

Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 2

Condition
Alcohol Use Disorder
Intervention / Treatment

-

Contacts and Locations

Decatur

Atlanta VA Medical Center, Decatur, Georgia, United States, 30033

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * diagnosed with HIV
  • * Receive care at the Atlanta VA Healthcare System
  • * Are 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
  • * Currently smoking cigarettes
  • * Prescribed \>=5 medications
  • * Have cell phone or reliable contact number
  • * Can provide written informed consent
  • * 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
  • * History of serious hypersensitivity or adverse reaction to study medication
  • * Taking potentially interactive medication(s) (e.g. nicotine replacement therapy for varenicline pilot study)
  • * Already prescribed the pilot medication at the time of study recruitment

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Yale University,

E. Jennifer Edelman, MD, MHS, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

2025-12-31