Clinical Trial to Reduce Drinking in Women With HIV

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.

Conditions

• HIV Infection

Interventions

DRUG

Naltrexone

The study involves taking the drug naltrexone for up to 4 months. This will be given in a single pill each day for 4 months.

DRUG

Placebo

Placebo is an inert pill that looks the same as naltrexone. The placebo will be taken once each day for up to 4 months.

Sponsors & Collaborators

• Florida International University

  collaborator OTHER

• University of Miami

  collaborator OTHER

• Rush University

  collaborator OTHER

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  collaborator NIH

• University of Florida

  lead OTHER

Principal Investigators

• Robert L Cook, MD, MPH · University of Florida

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-12-31

Primary Completion

2016-07-31

Completion

2016-07-31

FDA Drug

Yes

Countries

• United States

Study Locations