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
| Autor: | Mary Young, Babette Brumback, Mobeen H. Rathore, Robert L. Cook, Kathleen M. Weber, Kendall J. Bryant, Manju Karki, Dao Mai, Xingdi Hu, Mardge H. Cohen, Kathleen A. Thoma |
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| Rok vydání: | 2017 |
| Předmět: |
Adult
medicine.medical_specialty Substance-Related Disorders Narcotic Antagonists Population Human immunodeficiency virus (HIV) HIV Infections Pilot Projects medicine.disease_cause Placebo Article Naltrexone Medication Adherence law.invention 03 medical and health sciences 0302 clinical medicine Double-Blind Method Acquired immunodeficiency syndrome (AIDS) Randomized controlled trial law Internal medicine medicine Humans Pharmacology (medical) 030212 general & internal medicine Psychiatry education education.field_of_study business.industry General Medicine Middle Aged medicine.disease Black or African American Clinical trial Alcoholism Female business Alcohol consumption 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | Contemporary Clinical Trials. 60:72-77 |
| ISSN: | 1551-7144 |
| DOI: | 10.1016/j.cct.2017.06.012 |
| Popis: | 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.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-related outcomes.From 2010 to 2012, 17 women enrolled (mean age 49years, 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, p0.01) with continued reduction maintained at 7-months. Drinking reductions were similar in both naltrexone and placebo groups.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. |
| Databáze: | OpenAIRE |
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