Pharmacotherapy for HIV Infected Patients With Alcohol Problems

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: NCT00854230
Recruitment Status : Withdrawn (We expanded to a bigger, multi-site study & decided to close this study.)
First Posted : March 3, 2009
Last Update Posted : March 28, 2012
Yale University
Information provided by (Responsible Party):
VA Connecticut Healthcare System

March 2, 2009
March 3, 2009
March 28, 2012
January 2009
January 2010   (Final data collection date for primary outcome measure)
Frequency of heavy drinking [ Time Frame: 12 weeks ]
Same as current
Complete list of historical versions of study NCT00854230 on Archive Site
  • HIV biological markers [ Time Frame: 12 weeks ]
  • Sexual risk behavior [ Time Frame: 12 weeks ]
  • Tolerability and retention in alcohol treatment [ Time Frame: 12 weeks ]
Same as current
Not Provided
Not Provided
Pharmacotherapy for HIV Infected Patients With Alcohol Problems
Pharmacotherapy for HIV Infected Patients With Alcohol Problems

This is a randomized double blind clinical trial to test the effect of Naltrexone on HIV infected heavy drinkers. The study will select 40 HIV positive patients who meet criteria for heavy drinking. Treatments include Naltrexone (25-100mg)and placebo. Patients will be treated, followed up, and assessed for a duration of 12 weeks.

The investigators associated hypotheses Hypothesis 1: Naltrexone will reduce the frequency of heavy drinking. Hypothesis 2: Naltrexone will lead to maintenance or improvement in CD4 lymphocyte count and decreased HIV RNA levels.

Hypothesis 3: Naltrexone will lead to a reduction in sexual risk behaviors. Hypothesis 4: Naltrexone will lead to improved adherence to HAART. Hypothesis 5 (Exploratory): Naltrexone will be well-tolerated with minimal side effects and patients will exhibit good treatment retention.

Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • HIV Infection
  • Heavy Alcoholic Consumption
  • HIV Infections
Drug: Naltrexone
Naltrexone dose 25-100mg
Other Name: Revia
  • Experimental: 1
    Intervention: Drug: Naltrexone
  • Placebo Comparator: 2
    Intervention: Drug: Naltrexone
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2010
January 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Be HIV-positive.
  2. Report heavy drinking 4 or more times in the past 4 weeks. Heavy drinking is defined as 4 or more drinks for women and 5 or more drinks for men on any occasion.
  3. Not be abstinent from alcohol for greater than 30 days.
  4. Be at least 18 years old.
  5. Be able to understand English and provide informed consent

Exclusion Criteria:

  1. Be psychotic or severely psychiatrically disabled.
  2. Have medical conditions that would preclude completing or be of harm during the course of the study.
  3. Have laboratory or clinical evidence of significant liver dysfunction (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of the normal range) or cirrhosis.
  4. Have a known contraindication to naltrexone therapy (e.g. taking opioid medication for pain).
  5. Be pregnant, nursing or unable to use an effective method of birth control (women).
  6. Subjects who are taking or use narcotics will not be included because naltrexone will precipitate withdrawal.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
Not Provided
Not Provided
VA Connecticut Healthcare System
VA Connecticut Healthcare System
Yale University
Principal Investigator: David A Fiellin, Md Yale University
Principal Investigator: Amy Justice, MD, PhD Yale University, West Haven VA hospital
VA Connecticut Healthcare System
March 2012

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