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| ID | Type | Description | Link |
|---|---|---|---|
| 1P01AA029545-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spironolactone | Experimental | Participants will receive a prescription for spironolactone |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spironolactone | Drug | All participants will receive a prescription for spironolactone and will meet with a clinical pharmacist and addiction psychiatrist for further support |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 weeks |
| Number of sessions completed | Number of sessions completed to assess acceptability of study | 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 | 12 weeks |
| Safety of study assessed by adverse events reporting | Safety will be assessed by the percentage of study participants who report adverse events | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Efficacy of study - change in PEth (phosphatidylethanol) results |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| E. Jennifer Edelman, MD, MHS | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlanta VA Medical Center | Decatur | Georgia | 30033 | United States |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013148 | Spironolactone |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 |
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Single arm
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PEth is a biomarker for alcohol consumption. Change in PEth result from baseline PEth levels.
| 12 weeks |
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |