Acceptability and feasibility of a randomized clinical trial of oral naltrexone vs. placebo for women living with HIV infection: Study design challenges and pilot study results.

ABSTRACT:

Background

Women living with HIV/AIDS who drink alcohol are at increased risk for adverse health outcomes, but there is little evidence on best methods for reducing alcohol consumption in this population. We conducted a pilot study to determine the acceptability and feasibility of conducting a larger randomized clinical trial of naltrexone vs. placebo to reduce alcohol consumption in women living with HIV/AIDS.

Methods

We designed the trial with input from community and scientific review. Women with HIV who reported current hazardous drinking (>7 drinks/week or ≥4 drinks per occasion) were randomly assigned to daily oral naltrexone (50mg) or placebo for 4months. We evaluated willingness to enroll, adherence to study medication, treatment side effects, and drinking and HIV-re

SUBMITTER: Cook RL 

PROVIDER: S-EPMC5570613 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature