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Completed

NCT Number: NCT01377168

Naltrexone for Medication Compliance Among HIV-infected Men With Alcohol Use Disorder

This study will recruit 159 HIV-infected men with alcohol use disorders (AUDs). Men will be randomized to receive either oral naltrexone for the treatment of alcohol use disorder or placebo. Men with acute, recent or established HIV infection will receive antiretroviral treatment (ART) and be randomized to oral naltrexone or placebo. The purpose of this study is to see whether use of oral naltrexone improves medication compliance, and therefore HIV viral load suppression, among men with alcohol use disorder. The study will also assess the impact of oral naltrexone on alcohol use behaviors in this population.

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Key information

Conditions

HIV Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Asociación Civil Impacta Salud y Educación

Lima, Peru

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meets DSM-IV criteria for alcohol dependence or problem drinking.
  • Age 18 years and older
  • Confirmed HIV infection, either through positive HIV antibody or detectable HIV-1 RNA level.
  • No participation in pharmacotherapy trial in the previous 30 days
  • Not pregnant

Exclusion criteria

  • Unable to provide informed consent
  • Verbally or physically threatening to research staff
  • Unable to communicate in Spanish
  • Pending trials for a felony
  • Childs-Pugh Class C Cirrhosis
  • Grade 3 Hepatitis (LFTs > 5X normal)
  • Receiving opioid prescription narcotics or has pain syndrome necessitating future use of opioid prescription narcotics.

Treatment and study plan

oral naltrexone

Drug

Other names: Nalerona

Placebo pill

Drug

Primary outcomes

  1. HIV Viral Load Suppression

    Time frame: 6 months

    The primary outcome will be the proportion with a VL<400 copies/mL at 6 months.

Secondary outcomes

  1. ART Compliance and Alcohol Use Behavior

    Time frame: 6 months

    Secondary HIV outcomes will include time to ART initiation, retention on ART over 6 months, and HIV sexual risk behaviors. Alcohol use outcomes include the following: 1) Time to relapse to heavy drinking (for men defined as >5 drinks/drinking day); 2) percent of days drinking (PDD) over the six-month examination period; 3) percent of days abstinent (PDA) over the six month examination period; and 4) alcohol craving using the Obsessive Compulsive Drinking Scale where a mean change in total score will be assessed and compared between treatment groups.

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • Asociación Civil Impacta Salud y Educación, Peru
  • Yale University

Registry information

Official study title

Oral Naltrexone for Improved Medication Compliance Among HIV-infected Men With Alcohol Use Disorder

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jun 21, 2011
Registry last updated
Jun 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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