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Clinical Trial to Reduce Drinking in Women With HIV (WHATIF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01625091
Recruitment Status : Completed
First Posted : June 21, 2012
Results First Posted : August 2, 2017
Last Update Posted : July 10, 2018
Florida International University
University of Miami
Rush University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE June 12, 2012
First Posted Date  ICMJE June 21, 2012
Results First Submitted Date  ICMJE July 6, 2017
Results First Posted Date  ICMJE August 2, 2017
Last Update Posted Date July 10, 2018
Actual Study Start Date  ICMJE December 2012
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2017)
Number of Participants Who Quit Hazardous Drinking [ Time Frame: Month 4 ]
The primary statistical outcome for the trial is alcohol consumption at month 4 when the drug is stopped. This main outcome is a categorical variable of either quit hazardous drinking (defined as ≤7 drinks per week and <4 drinks on any single day in the past 30 days), or did not quit (drinking exceeds the hazardous amount) .
Original Primary Outcome Measures  ICMJE
 (submitted: June 18, 2012)
Alcohol Consumption [ Time Frame: Month 4 ]
The primary statistical outcome for the trial is alcohol consumption at month 4 when the drug is stopped.
Change History Complete list of historical versions of study NCT01625091 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2017)
  • Number of Binge Drinking Days [ Time Frame: Month 4 ]
    In the past 30 days, total number of days with binge drinking which was defined as consuming ≥4 drinks on a single day (measured by Timeline Follow Back).
  • Drinking Problems (SIP-2R Score) [ Time Frame: 4 months ]
    The Short Inventory of Problems (SIP-2R) seeks to measure the consequences of drinking in participants through questions related to guilt, reliability etc. The SIP-2R has 15 items asking how often the event happened during the past 3 months. Each item has a score from 0-3 (0=Never, 1=once or a few times, 2=once or twice a week, 3=daily or almost daily). The 15 questions from the SIP-2R are summed to create a total range of scores from 0-45.
  • Craving for Alcohol [ Time Frame: 4 months ]
    Self-reported scale of alcohol craving ranging from 0 (no craving) to 10 (strongest craving)
Original Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2012)
Alcohol related HIV problems [ Time Frame: Month 4 ]
The investigators will assess secondary outcomes for participants that include other measures of alcohol consumption : medication adherence, risky sexual behaviors and HIV clinical status (CD4 count, HIV viral load)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Clinical Trial to Reduce Drinking in Women With HIV
Official Title  ICMJE Pharmacotherapy for Alcohol Consumption in HIV Infected Women: Randomized Trial
Brief 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.

Detailed Description

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 participating in 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 theorize that women who receive an alcohol treatment intervention will be less likely to have "at risk" 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 who 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 240 women from one site in Miami, Florida. Of those 240 women 120 will receive naltrexone and the others 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 months 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 affect 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE HIV Infection
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: naltrexone
    The investigators will administer Naltrexone to women with hazardous drinking and assess the study outcomes.
    Intervention: Drug: Naltrexone
  • Placebo Comparator: placebo pill
    The investigators will administer an inert placebo that looks similar to Naltrexone, to women with hazardous drinking and assess the study outcomes.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 23, 2017)
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2012)
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01625091
Other Study ID Numbers  ICMJE 86-2012-N
U01AA020797-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE
  • Florida International University
  • University of Miami
  • Rush University
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators  ICMJE
Principal Investigator: Robert L Cook, MD, MPH University of Florida
PRS Account University of Florida
Verification Date June 2018

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