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WithdrawnNCT00854230Updated Mar 28, 2012

Pharmacotherapy for HIV Infected Patients With Alcohol Problems

A Phase 4 interventional study of Naltrexone in HIV Infection, Heavy Alcoholic Consumption and HIV Infections, sponsored by VA Connecticut Healthcare System. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-28.

Sponsored by VA Connecticut Healthcare System · Phase 4, Interventional, and Treatment

Why this study was withdrawn
We expanded to a bigger, multi-site study \& decided to close this study.
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • HIV Infection
  • Heavy Alcoholic Consumption
  • HIV Infections

Keywords

  • HIV
  • alcohol
  • naltrexone
  • Treatment Experienced
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

Browse Infections studies →

Lead sponsor

VA Connecticut Healthcare System is the lead sponsor of 40 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    1

    Naltrexone

    Drug: Naltrexone

  • Placebo comparator
    2

    Drug: Naltrexone

Interventions

  • DrugNaltrexone

    Naltrexone dose 25-100mg

    Also known as: Revia

06

What researchers measure

Primary outcomes

  1. Frequency of heavy drinking

    Time frame: 12 weeks

Secondary outcomes

  1. HIV biological markers

    Time frame: 12 weeks

  2. Sexual risk behavior

    Time frame: 12 weeks

  3. Tolerability and retention in alcohol treatment

    Time frame: 12 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00854230
Lead sponsor
VA Connecticut Healthcare System
Collaborators
Yale University
Responsible party
Sponsor
First posted
Mar 3, 2009
Start date
Jan 2009
Primary completion
Jan 2010
Completion
Jan 2010
Last update
Mar 28, 2012

Study contacts

David A Fiellin, Md
principal investigator · Yale University
Amy Justice, MD, PhD
principal investigator · Yale University, West Haven VA hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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