Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 1 (NCT06004830) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 1
United States30 participantsStarted 2023-11-06
Plain-language 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.
Who can participate
Age range18 Years – 99 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Proportion of participants who complete enrollment and duration of sessions
Timeframe: 12 weeks
2
Number of sessions completed
Timeframe: 12 weeks
3
Adherence to Medication
Timeframe: 12 weeks
4
Safety of study assessed by adverse events reporting