Will Having Alcohol Treatment Improve Functioning? (WHAT-IF)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01245647
First received: November 19, 2010
Last updated: January 10, 2014
Last verified: August 2013

November 19, 2010
January 10, 2014
November 2010
October 2012   (final data collection date for primary outcome measure)
Number of Drinks Per Week [ Time Frame: Month 4 ] [ Designated as safety issue: No ]
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.
Alcohol consumption [weekly quantity, frequency] [ Time Frame: month 4 ] [ Designated as safety issue: Yes ]
The primary statistical outcome for the trial is alcohol consumption at month 4 when the study drug is stopped. Our analysis will compare outcomes based on whether the participant is in the naltrexone or the placebo group.
Complete list of historical versions of study NCT01245647 on ClinicalTrials.gov Archive Site
  • HIV Medication Adherence (95% or Better) [ Time Frame: Month 4 ] [ Designated as safety issue: No ]
    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.
  • Risky Sexual Behaviors [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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.
  • HIV Viral Load Suppressed [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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)
  • CD4 Count (Mean) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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.
Alcohol and HIV-related problems [ Time Frame: month 4 ] [ Designated as safety issue: Yes ]
The investigators will assess additional secondary outcomes for participants that include other measures of alcohol consumption (i.e. number of binge episodes in previous 30 days, number of alcohol problems), medication adherence (continuous measure), risky sexual behaviors, and HIV clinical status (CD-4 count, HIV-viral-load). For each of these analyses, our analysis will simply compare outcomes based on whether the participant is in the naltrexone or the placebo group
Not Provided
Not Provided
 
Will Having Alcohol Treatment Improve Functioning?
Pharmacotherapy for Hazardous Drinking in HIV Infected Women: Randomized Trial

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.

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • HIV
  • Alcoholism
  • Drug: Naltrexone, 50mg, once per day for 4 months
    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 Name: Naltrexone
  • Other: Sugar pill, 50mg, once per day for 4 months
    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 Name: Inert sugar pill
  • Placebo Comparator: Sugar Pill, 50mg, once per day for 4 months
    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.
    Intervention: Other: Sugar pill, 50mg, once per day for 4 months
  • Active Comparator: Naltrexone, 50mg, once per day for 4 months
    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.
    Intervention: Drug: Naltrexone, 50mg, once per day for 4 months
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
October 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hazardous drinking: defined by the NIAAA as either of the following:

    1. binge drinking (4 or more drinks per occasion at least twice monthly), (NIAAA 2005) - OR
    2. 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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01245647
AA018934-01, R01AA018934-01
No
University of Florida
University of Florida
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Robert L Cook, MD, MPH University of Florida
University of Florida
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP