Clinical Trial to Reduce Drinking in Women With HIV

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Florida
• Collaborators: Florida International University; National Institute on Alcohol Abuse and Alcoholism (NIAAA); Rush University; University of Miami
• Treatments: Naltrexone

Criteria

Inclusion Criteria: (must meet all of following):

• Hazardous drinking, on average, during the preceding 4 weeks. Defined as binge drinking (4 or more drinks per occasion at least twice monthly) and/or high total weekly consumption (>7 drinks per week).

• Age 18 or over

• Female

• HIV infection (documented by medical record blood test result or testing done for this study)

• Able to understand and comply with study procedures and to provide written consent.

Exclusion criteria: (cannot have any of the following):

• Contraindications to treatment with naltrexone

• Current physiologic opiate dependence

• Current daily prescription opioid medications

• Positive urine drug test for opioids

• Allergic to naltrexone

• Significantly abnormal baseline liver enzymes (AST or ALT >=5 times upper normal), evidence of acute hepatitis, or receiving hemodialysis for renal failure

• Currently pregnant

• Currently taking an alcohol treatment medication (disulfiram, topiramate, naltrexone, acamprosate).

• Currently unable to provide mailing address or reliable contact information, or has plans to move from area within next 7 months

• Unable to communicate in English or Spanish

• Research coordinator assessment that participant cannot comprehend the study or consent procedures (e.g. participant appears to be intoxicated, answers questions in a non-sensible manner)

• Has current prognosis of less than one year to live (e.g. in Hospice, has metastatic cancer)

• Currently taking antiviral treatment for hepatitis C infection (interferon or ribavirin)

• Has other unique health condition, not specifically listed, that should exclude the participant after discussion with Dr. Cook, Dr. Espinoza, and perhaps also the participant's primary HIV physician (for example an unexpected abnormal laboratory result turns up on the baseline screening metabolic panel).