Pharmacotherapy for Hazardous Drinking in HIVInfected Women: A Randomized, Clinical Trial

Investigator: John Lewis

Institutional Protocol #: 20120021

National Clinical Trials Identifier: NCT01625091

Funding Agency/Sponsor: Intramural

Division: Psychiatry

Therapeutic Area:

Phase: N/A

Enrolling Sites: Jackson Memorial Hospital, University of Miami Medical Group

Enrolling Since: 3/6/2017


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.

Eligibility 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

- 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,

- 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

- Currently taking antiviral treatment for hepatitis C infection (interferon or

- 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).

Gender: Female

Minimum Age: 18 Years

Maximum Age: N/A

Accepts healthy volunteers: Accepts Healthy Volunteers

Please note that this is written for scientific review, and if there are any questions or clarifications needed, please contact

John Lewis, Research Assoc. Professor
(305) 243 6227


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