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

Hiv Clinical Trial

— HARP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06006143
• Other study ID #: 2000033919_b
• Secondary ID: 1P01AA029545-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2025
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Yale University
• Contact: E. Jennifer Edelman, MD, MHS
• Phone: 203-737-7115
• Email: ejennifer.edelman[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 among individuals with HIV and AUD.

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 varenicline in the first 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 if score >/=7, the Alcohol Symptom Checklist at the start of the study period. Several assessments including interviews and laboratory testing will be done at study visits.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diagnosed with HIV

• Receive care at the Atlanta VA Healthcare System

• Are age 18 or over

• Meet criteria for moderate to severe alcohol use disorder by the DSM-5 Alcohol Symptom Checklist

• Score >7 on 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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• Hiv
• Tobacco Use Disorder

Intervention

Drug:
• Varenicline
All participants will receive a prescription for varenicline and will meet with a clinical pharmacist and addiction psychiatrist for further support

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 weeks
Primary	Number of sessions completed	Number of sessions completed to assess acceptability of study	12 weeks
Primary	Adherence to Medication	Medication adherence will be measured by the number of prescriptions filled by electronic health record to assess acceptability of study	12 weeks
Primary	Safety of study assessed by adverse events reporting	Safety will be assessed by the percentage of study participants who report adverse events	12 weeks
Secondary	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.	12 weeks
Secondary	Efficacy of study - change in PEth (phosphatidylethanol) results	PEth is a biomarker for alcohol consumption. Change in PEth result from baseline PEth levels.	12 weeks