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Completed

NCT Number: NCT00620750

Extended-release Naltrexone for Alcohol Dependence in Primary Care

Naltrexone is an opioid antagonist with a high affinity for the mu opioid receptor. The efficacy of extended-release naltrexone (Vivitrol) as a treatment for alcohol dependence has been demonstrated in clinical trials, raising the prospect of integrating pharmacologic treatment for alcohol dependence into general medical care settings. However, the feasibility of implementing this United States Food and Drug Administration approved treatment in the front-line settings in which it is most needed has not been demonstrated. This is an open-label pilot feasibility study of implementing treatment with Vivitrol in primary care medical clinics in a safety net hospital system affiliated with an urban academic center.

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Key information

Conditions

Alcohol Dependence Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

NYU School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Current alcohol dependence
  • Age 18 or older
  • English or Spanish-speaking
  • Without untreated severe mental illness
  • Liver enzymes (alanine aminotransferase and aspartate aminotransferase) ≤ 3x normal
  • Kept 2 of last 3 clinic primary care appointments and/or has a working telephone number at which can be contacted directly
  • Either a) currently abstinent (e.g., referred from an inpatient 'detox' setting) or b) with the ability, in the clinician's judgment, to achieve and maintain abstinence
  • If female of child-bearing potential, must be using adequate contraception
  • Able to understand study procedures

Exclusion criteria

  • Currently opioid dependent or requiring ongoing treatment with opioids for any indication

Treatment and study plan

Extended release injectable naltrexone (Vivitrol)

Drug

Three sequential monthly injections of extended release injectable naltrexone (Vivitrol), with option to extend participation for an additional 12 months.

Other names: Vivitrol

Primary outcomes

  1. Percent of Patients Initiating Vivitrol Treatment Who Receive 3 Consecutive Monthly Vivitrol Injections

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Alkermes, Inc.

Registry information

Official study title

Extended-release Naltrexone (Vivitrol) for the Treatment of Alcohol Dependence in Urban Primary Care: a Feasibility Study

Important dates

Study start
2007
Primary completion
2008
Study completion
2010
First posted
Feb 21, 2008
Registry last updated
Sep 27, 2011

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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