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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of Florida
Sponsor:
Collaborators:
Florida International University
University of Miami
Rush University
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01625091
First received: June 12, 2012
Last updated: October 21, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
HIV Infection
Drug: Naltrexone
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacotherapy for Alcohol Consumption in HIV Infected Women: Randomized Trial

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Alcohol Consumption [ Time Frame: Month 4 ] [ Designated as safety issue: Yes ]
    The primary statistical outcome for the trial is alcohol consumption at month 4 when the drug is stopped.


Secondary Outcome Measures:
  • HIV medication adherence [ Time Frame: Month 4 ] [ Designated as safety issue: No ]
  • risky sexual behavior [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • HIV disease progression [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Measured by changes in HIV viral load and CD4 count


Estimated Enrollment: 240
Study Start Date: December 2012
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: naltrexone
The investigators will administer Naltrexone to women with hazardous drinking and assess the study outcomes.
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.
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01625091

Contacts
Contact: Robert L Cook, MD, MPH 352-273-5869 cookrl@phhp.ufl.edu

Locations
United States, Florida
University of Miami Recruiting
Coral Gables, Florida, United States, 33124
Principal Investigator: John E Lewis, PhD         
Principal Investigator: Luis Espinoza, MD         
Florida International University Recruiting
Miami, Florida, United States
Contact: Clery Quiros, MPH    305-355-7056      
Principal Investigator: Maria Miguez, MD, PhD         
Sponsors and Collaborators
University of Florida
Florida International University
University of Miami
Rush University
Investigators
Principal Investigator: Robert L Cook, MD, MPH University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01625091     History of Changes
Other Study ID Numbers: U01 AA020797-01
Study First Received: June 12, 2012
Last Updated: October 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Florida:
HIV
women
drinking
Naltrexone

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Naltrexone
Central Nervous System Agents
Narcotic Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014