Clinical trial

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

Name

2000033919_b

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.

Trial arms

Trial start

2025-01-01

Estimated PCD

2025-12-31

Trial end

2025-12-31

Status

Not yet recruiting

Treatment

Varenicline

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

Arms:

Varenicline

Size

Primary endpoint

Proportion of participants who complete enrollment and duration of sessions

12 weeks

Number of sessions completed

12 weeks

Adherence to Medication

12 weeks

Safety of study assessed by adverse events reporting

12 weeks

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single arm', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

Updated at

2024-06-10

1 organization

1 product

3 indications

Organization

Product

Indication

Indication

Indication