Using off-label medications to treat alcohol use disorder in HIV patients
Feasibility, Acceptability, and Preliminary Efficacy of Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: An Open-Label Pilot Study
This study is testing whether a combination of certain medications, counseling, and support can help people with both HIV and alcohol use disorder reduce their drinking and stick to their treatment plan.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (Decatur, Georgia) |
| Trial ID | NCT06004830 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the feasibility, acceptability, and preliminary efficacy of an intervention that combines off-label medication use with medical management and behavioral counseling for individuals diagnosed with both HIV and alcohol use disorder (AUD). Participants will receive a 12-week intervention that includes counseling techniques designed to motivate behavior change regarding alcohol consumption and medication adherence. The study will assess participants' perspectives on the intervention's feasibility and acceptability, as well as monitor their alcohol use through various assessments and laboratory tests.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and over, diagnosed with HIV, who meet the criteria for mild, moderate, or severe alcohol use disorder and are prescribed five or more medications.
Not a fit: Patients currently engaged in formal alcohol treatment or those with untreated moderate to severe opioid use disorder may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a new approach to effectively reduce alcohol consumption among patients with HIV and AUD.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using off-label medications for AUD, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * diagnosed with HIV * Receive care at the Atlanta VA Healthcare System * 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 * 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): eplerenone, potassium supplementation, lithium, digoxin, cholestyramine, heparin and low-molecular weight heparin for spironolactone) * Hyperkalemia defined as serum potassium ≥ 5.0 mEq/L on the most recent laboratory test performed in the past 60 days prior to enrollment or Addison's disease or estimated glomerular filtration rate \<50 mL/min/1.73 m2 (for spironolactone) * Creatinine level of ≥1.5 mg/dl (for spironolactone) * Already prescribed the pilot medication at the time of study recruitment.
Where this trial is running
Decatur, Georgia
- Atlanta VA Medical Center — Decatur, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: E. Jennifer Edelman, MD, MHS — Yale University
- Study coordinator: E. Jennifer Edelman, MD, MHS
- Email: ejennifer.edelman@yale.edu
- Phone: 203-737-7115
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.