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

Launched by YALE UNIVERSITY · Aug 16, 2023

Keywords

ClinConnect Summary

This clinical trial, titled "Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 2," is designed to explore a new way to help people with HIV who also struggle with alcohol use. The study will test a medication that is not normally used for this purpose, combined with support from healthcare professionals, to see if it can effectively reduce alcohol consumption in these individuals. Researchers want to find out if this approach is acceptable and feasible for patients, meaning they want to see if people are willing to participate and if the treatment can be easily integrated into their care.

To be eligible for this study, participants must be at least 18 years old, have been diagnosed with HIV, and meet certain criteria for alcohol use disorder. This includes having significant alcohol use and currently smoking cigarettes. Participants should also be receiving care at the Atlanta VA Healthcare System and must be taking at least five medications. However, individuals who are already receiving formal treatment for alcohol problems or have certain serious health conditions will not be eligible. If someone chooses to participate, they can expect to receive a combination of medication and behavioral support aimed at reducing their alcohol use. This trial is currently not recruiting, but it aims to gather important information for improving treatment options for people with HIV and alcohol use issues.

Gender

ALL

Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• • 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