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Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 1 (HARP)

Primary Purpose

Alcohol Use Disorder, Hiv

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Spironolactone
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: diagnosed with HIV Receive care at the Atlanta VA Healthcare System 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 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Spironolactone

    Arm Description

    Participants will receive a prescription for spironolactone

    Outcomes

    Primary Outcome Measures

    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
    Number of sessions completed
    Number of sessions completed to assess acceptability of study
    Adherence to Medication
    Medication adherence will be measured by the number of prescriptions filled by electronic health record to assess acceptability of study
    Safety of study assessed by adverse events reporting
    Safety will be assessed by the percentage of study participants who report adverse events

    Secondary Outcome Measures

    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.
    Efficacy of study - change in PEth (phosphatidylethanol) results
    PEth is a biomarker for alcohol consumption. Change in PEth result from baseline PEth levels.

    Full Information

    First Posted
    August 16, 2023
    Last Updated
    October 11, 2023
    Sponsor
    Yale University
    Collaborators
    National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06004830
    Brief Title
    Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 1
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 16, 2023 (Anticipated)
    Primary Completion Date
    August 31, 2024 (Anticipated)
    Study Completion Date
    August 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Yale University
    Collaborators
    National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcohol Use Disorder, Hiv

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Single arm
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Spironolactone
    Arm Type
    Experimental
    Arm Description
    Participants will receive a prescription for spironolactone
    Intervention Type
    Drug
    Intervention Name(s)
    Spironolactone
    Intervention Description
    All participants will receive a prescription for spironolactone and will meet with a clinical pharmacist and addiction psychiatrist for further support
    Primary Outcome Measure Information:
    Title
    Proportion of participants who complete enrollment and duration of sessions
    Description
    Proportion of participants who complete enrollment and duration of sessions to assess feasibility of study
    Time Frame
    12 weeks
    Title
    Number of sessions completed
    Description
    Number of sessions completed to assess acceptability of study
    Time Frame
    12 weeks
    Title
    Adherence to Medication
    Description
    Medication adherence will be measured by the number of prescriptions filled by electronic health record to assess acceptability of study
    Time Frame
    12 weeks
    Title
    Safety of study assessed by adverse events reporting
    Description
    Safety will be assessed by the percentage of study participants who report adverse events
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Efficacy of study - change in self-reported alcohol use
    Description
    Change in self-reported alcohol use (# of days of alcohol use and # of drinks per day) on the Timeline Followback.
    Time Frame
    12 weeks
    Title
    Efficacy of study - change in PEth (phosphatidylethanol) results
    Description
    PEth is a biomarker for alcohol consumption. Change in PEth result from baseline PEth levels.
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: diagnosed with HIV Receive care at the Atlanta VA Healthcare System 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 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    E. Jennifer Edelman, MD, MHS
    Phone
    203-737-7115
    Email
    ejennifer.edelman@yale.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    June-Marie Weiss, MA, MEd
    Phone
    203-737-3347
    Email
    junemarie.weiss@yale.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    E. Jennifer Edelman, MD, MHS
    Organizational Affiliation
    Yale School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 1

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