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Completed

NCT Number: NCT01245647

Will Having Alcohol Treatment Improve Functioning?

The purpose of the study is to find out if a medication,naltrexone is helpful for HIV-infected women who sometimes drink too much. The study will try to find out whether women like the medication, whether the medication helps them cut back on their drinking, and whether it helps improve their overall health. Naltrexone has not been used widely among people who are engaged in less severe drinking and in primary health care settings. Therefore, the investigators would like to determine whether it is helpful among women who sometimes drink 4 or more drinks per occasion or 7 or more drinks per week. The investigators hypothesize that by taking naltrexone, women with hazardous drinking pattern will reduce their drinking which in turn will improve their medication adherence, improve their health and quality of life.

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Key information

Conditions

HIV Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Women's Interagency HIV Study, Washington D.C., District of Columbia, United States

Loading trial locations.

About this study

The primary objective of this study is to evaluate the acceptability and effectiveness of a treatment program for hazardous drinking, delivered within HIV-clinic outpatient settings, that involves oral naltrexone. The central hypothesis is that women randomized to the treatment program will have decreased rates of hazardous drinking and improved clinical and behavioral health outcomes that are associated with hazardous drinking. The investigators have formulated this hypotheses based on the existing literature, the preliminary data and the clinical experience. The investigators hypothesize that women randomized to receive an alcohol treatment intervention will be less likely to have hazardous drinking behavior 6-months after enrollment, compared to women who received similar assessments but no formal treatment intervention. The investigators hypothesize that 4-months after enrollment, women randomized to receive an alcohol treatment intervention will have improved adherence to HIV antiretroviral therapy, improved CD4 cell counts, reduced HIV viral load, and reduced risky sexual behavior, compared to women who receive similar assessments but no formal intervention.

The investigators will recruit 90 women from 3 different sites in Florida, Washington DC and Chicago. Of those 90 women 60 will receive naltrexone and 30 will receive placebo. Study participants will take the medication for 4 months but the investigators will follow them for 7 months. At baseline, 2 months, 4 months and 7 months, the investigators will administer study questionnaires and assess their liver enzymes, CD4 count and viral load. The investigators will also follow them up at month 1 and 3 to reinforce the medication intake and to assess for any possible side effects.

New treatment options are available, but their impact on hazardous drinking has not yet been evaluated among HIV-infected women, many of whom are poor, minorities, or who have associated mental health or substance abuse problems. Delivery of therapeutic interventions must be improved in order to reduce hazardous drinking in women with HIV/AIDS. The proposed research is significant because the therapy will be offered within HIV clinic settings and will potentially improve the health of a population that is significantly undertreated. In addition to determining the effectiveness of an alcohol treatment intervention, the investigators will also identify key barriers and facilitators associated with adherence to pharmacologic treatment for alcohol in women with hazardous drinking. The findings will directly impact the type and quality of care for hazardous drinking in this subset of HIV-infected individuals and will inform both primary and secondary prevention efforts

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hazardous drinking: defined by the NIAAA as either of the following:
  • binge drinking (4 or more drinks per occasion at least twice monthly), (NIAAA 2005) - OR
  • high quantity-frequency (>7 or drinks per week)
  • Age 18 or over
  • Female
  • HIV-infected documented by a rapid HIV test or any licensed ELISA test kit and confirmed by a repeat ELISA, Western Blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA viral load or a second antibody test by a method other than ELISA at any time prior to study entry.
  • Able to understand and comply with planned study procedures.
  • Willing and able to provide informed consent.

Exclusion criteria

  • 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 normal); on dialysis for renal failure
  • currently taking oral medications for tuberculosis.
  • Currently pregnant or positive pregnancy test.
  • currently breastfeeding.
  • Currently taking an alcohol treatment medication (disulfiram, topiramate, naltrexone, acamprosate).
  • currently homeless, unable to provide mailing address, or has plans to move from area within next 7 months.
  • Unable to communicate in English.
  • Research coordinator assessment that participant cannot comprehend the study or consent procedures
  • Has current prognosis of less than 1 year to live
  • Abnormal vital signs at enrollment visit
  • Currently on treatment for Hepatitis C (HCV) infection
  • Prisoner status

Treatment and study plan

Naltrexone, 50mg, once per day for 4 months

Drug

Naltrexone: Two thirds of the total study participants will receive the medication naltrexone. Each study participant will take a single pill once a day for 4 months.

Other names: Naltrexone

Sugar pill, 50mg, once per day for 4 months

Other

Placebo: One third of the participants will receive placebo pills that look the same as the active comparator but are really just inert pills. Each study participant will take a single pill once a day for 4 months.

Other names: Inert sugar pill

Primary outcomes

  1. Number of Drinks Per Week

    Time frame: Month 4

    Average number of standard alcohol drinks per week, as measured by timeline follow-back. A drink typically contains about 0.6 grams of alcohol, and generally represents 1 12-oz beer, 1 5-oz glass of wine, or one shot of liquor.

Secondary outcomes

  1. HIV Medication Adherence (95% or Better)

    Time frame: Month 4

    Medication adherence was measured on a visual analogue scale ranging from 0 - 100, and indicating what percentage of the persons' HIV medication was taken on schedule over the past week (self-report). A score of 95% or better was considered adherent, and we report the proportion of persons who were adherent in each group.

  2. Risky Sexual Behaviors

    Time frame: 4 months

    Risky sexual behavior was a dichotomous outcome for each participant at each time point, defined as having any non-condom-protected sex with a males who have an unknown/negative HIV status in the previous 30 days.

  3. HIV Viral Load Suppressed

    Time frame: 4 months

    Viral load was classified as either suppressed (HIV viral load <50 copies/ml) or not suppressed (HIV viral load >50 copies/ml). We report the proportion of participants who had a suppressed viral load (higher number is better)

  4. CD4 Count (Mean)

    Time frame: 4 months

    Results from CD4 cell count result obtained either as lab specifically for this study, or from lab results that were collected at the same time point for a different study or clinical indication.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Pharmacotherapy for Hazardous Drinking in HIV Infected Women: Randomized Trial

Acronym: WHAT-IF

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 22, 2010
Registry last updated
May 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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