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

作者：Cook Robert L; Weber Kathleen M; Mai Dao; Thomas Kathleen; Hu Xingdi; Brumback Babette; Karki Manju; Bryant Kendall; Rathore Mobeen; Young Mary; Cohen Mardge

来源：Contemporary Clinical Trials, 2017, 60: 72-77.

DOI：10.1016/j.cct.2017.06.012

• Alcohol consumption
• Women
• HIV infection
• Clinical trial
• Naltrexone
• HIV viral suppression

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 (50 mg) or placebo for 4 months. We evaluated willingness to enroll, adherence to study medication, treatment side effects, and drinking and HIV-related outcomes.
Results: From 2010 to 2012, 17 women enrolled (mean age 49 years, 94% African American). Study participation was higher among women recruited from an existing HIV cohort study compared to women recruited from an outpatient HIV clinic. Participants took 73% of their study medication; 82% completed the final assessment (7-months). Among all participants, mean alcohol consumption declined substantially from baseline to month 4 (39.2 vs. 12.8 drinks/week, p < 0.01) with continued reduction maintained at 7-months. Drinking reductions were similar in both naltrexone and placebo groups.
Conclusions: A pharmacologic alcohol intervention was acceptable and feasible in women with HIV, with reduced alcohol consumption noted in women assigned to both treatment and placebo groups. However, several recruitment challenges Were identified that should be addressed to enhance recruitment in future alcohol treatment trials.

• 出版日期2017-9
• 单位河北医科大学