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.
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 spironolactone 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 the Alcohol Symptom Checklist at the start of the study period to screen for mild, moderate, or severe AUD. Several assessments including interviews and laboratory testing will be done at study visits.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
All participants will receive a prescription for spironolactone and will meet with a clinical pharmacist and addiction psychiatrist for further support
Atlanta VA Medical Center
Decatur, Georgia, United States
RECRUITINGProportion of participants who complete enrollment and duration of sessions
Proportion of participants who complete enrollment and duration of sessions to assess feasibility of study
Time frame: 12 weeks
Number of sessions completed
Number of sessions completed to assess acceptability of study
Time frame: 12 weeks
Adherence to Medication
Medication adherence will be measured by the number of prescriptions filled by electronic health record to assess acceptability of study
Time frame: 12 weeks
Safety of study assessed by adverse events reporting
Safety will be assessed by the percentage of study participants who report adverse events
Time frame: 12 weeks
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.
Time frame: 12 weeks
Efficacy of study - change in PEth (phosphatidylethanol) results
PEth is a biomarker for alcohol consumption. Change in PEth result from baseline PEth levels.
Time frame: 12 weeks
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