Clinical Trial to Reduce Drinking in Women With HIV
Status:
Completed
Trial end date:
2016-07-01
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to evaluate whether an intervention that involves the
medication naltrexone, will reduce drinking and improve health outcomes in women with HIV
infection and hazardous drinking. Our central hypotheses are that, compared to women who
receive placebo (sugar pill containing no medicine), women who receive naltrexone will have
decreased rates of hazardous drinking, improved HIV medication adherence, less rapid disease
progression, and reduced sexual risk behavior. The study design will involve 240 HIV-infected
women with hazardous drinking, who will be recruited from HIV clinics, neighborhoods and
referrals in Miami, Florida.
Eligible women will receive either a daily pill containing naltrexone (50mg) or an
identical-appearing placebo for four months. All participants will receive encouragement and
feedback related to their drinking regardless of medication assignment. The study
participants will be assessed at two, four and seven months after enrollment. The proposed
work is innovative because pharmacologic treatment for alcohol has not been evaluated in
HIV-infected women. If our hypotheses are confirmed, the study findings would transform the
approach to hazardous drinking within clinics serving HIV-infected women.
Phase:
Phase 3
Details
Lead Sponsor:
University of Florida
Collaborators:
Florida International University National Institute on Alcohol Abuse and Alcoholism (NIAAA) Rush University University of Miami