Phase 2
N=19
Will Having Alcohol Treatment Improve Functioning?
HIV · Alcoholism
Bottom Line
View on ClinicalTrials.gov: NCT01245647 ↗Enrolled (actual)
19
Serious AEs
5.3%
Results posted
Feb 2014
Primary outcome: Primary: Number of Drinks Per Week — 13.8; 12.0 standard alcohol drinks per week — p=0.82
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Naltrexone, 50mg, once per day for 4 months (Drug); Sugar pill, 50mg, once per day for 4 months (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Florida
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Drinks Per Week |
13.8; 12.0 | 0.82 |
| SECONDARY HIV Medication Adherence (95% or Better) |
50; 50 | 1.0 |
| SECONDARY Risky Sexual Behaviors |
0; 29 | 0.46 |
| SECONDARY HIV Viral Load Suppressed |
43; 88 | 0.12 |
| SECONDARY CD4 Count (Mean) |
669; 761 | 0.67 |
Summary
The purpose of the study is to find out if a medication,naltrexone is helpful for HIV-infected women who sometimes drink too much. The study will try to find out whether women like the medication, whether the medication helps them cut back on their drinking, and whether it helps improve their overall health. Naltrexone has not been used widely among people who are engaged in less severe drinking and in primary health care settings. Therefore, the investigators would like to determine whether it is helpful among women who sometimes drink 4 or more drinks per occasion or 7 or more drinks per week. The investigators hypothesize that by taking naltrexone, women with hazardous drinking pattern will reduce their drinking which in turn will improve their medication adherence, improve their health and quality of life.
Eligibility Criteria
Inclusion Criteria
- Hazardous drinking: defined by the NIAAA as either of the following:
- binge drinking (4 or more drinks per occasion at least twice monthly), (NIAAA 2005) - OR
- high quantity-frequency (>7 or drinks per week)
- Age 18 or over
- Female
- HIV-infected documented by a rapid HIV test or any licensed ELISA test kit and confirmed by a repeat ELISA, Western Blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA viral load or a second antibody test by a method other than ELISA at any time prior to study entry.
- Able to understand and comply with planned study procedures.
- Willing and able to provide informed consent.
Exclusion Criteria
- Contraindications to treatment with naltrexone: current physiologic opiate dependence; current daily prescription opioid medications; positive urine drug test for opioids; allergic to naltrexone; significantly abnormal baseline liver enzymes (AST or ALT ≥ 5 times normal); on dialysis for renal failure
- currently taking oral medications for tuberculosis.
- Currently pregnant or positive pregnancy test.
- currently breastfeeding.
- Currently taking an alcohol treatment medication (disulfiram, topiramate, naltrexone, acamprosate).
- currently homeless, unable to provide mailing address, or has plans to move from area within next 7 months.
- Unable to communicate in English.
- Research coordinator assessment that participant cannot comprehend the study or consent procedures
- Has current prognosis of less than 1 year to live
- Abnormal vital signs at enrollment visit
- Currently on treatment for Hepatitis C (HCV) infection
- Prisoner status
Data sourced from ClinicalTrials.gov (NCT01245647). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.