RECRUITING

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

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Conditions

Alcohol Use DisorderHivTobacco Use Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-06-16
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06006143

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * diagnosed with HIV
  2. * Receive care at the Atlanta VA Healthcare System
  3. * Are age 18 or over
  4. * 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
  5. * Have evidence of significant alcohol use: PEth \> 20ng/ml
  6. * Currently smoking cigarettes
  7. * Prescribed \>=5 medications
  8. * Have cell phone or reliable contact number
  9. * Can provide written informed consent
  1. * Active engagement in formal alcohol treatment including medications for alcohol use disorder at the time of enrollment
  2. * Self-report or laboratory test confirming pregnancy, nursing, or trying to conceive
  3. * 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
  4. * Untreated moderate to severe opioid use disorder
  5. * Residence out of state
  6. * Inability to read or understand English
  7. * History of serious hypersensitivity or adverse reaction to study medication
  8. * Taking potentially interactive medication(s) (e.g. nicotine replacement therapy for varenicline pilot study)
  9. * Already prescribed the pilot medication at the time of study recruitment

Contacts and Locations

Study Contact

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

Principal Investigator

E. Jennifer Edelman, MD, MHS
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

Atlanta VA Medical Center
Decatur, Georgia, 30033
United States

Collaborators and Investigators

Sponsor: Yale University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-16
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2025-06-16
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Alcohol Use Disorder
  • Hiv
  • Tobacco Use Disorder