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Related Experiment Videos

Extended-release intramuscular naltrexone.

Tracy Swainston Harrison1, Greg L Plosker, Susan J Keam

  • 1Adis International Limited, Auckland, New Zealand.

Drugs
|September 19, 2006
PubMed
Summary

Extended-release naltrexone injections improve alcohol dependence treatment adherence. This 28-day formulation, combined with therapy, significantly reduced heavy drinking days compared to placebo.

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Area of Science:

  • Pharmacology
  • Addiction Medicine
  • Neuroscience

Background:

  • Alcohol dependence is a chronic relapsing disorder requiring effective long-term treatment strategies.
  • Improving patient adherence to medication is crucial for successful alcohol dependence management.
  • Traditional naltrexone formulations require daily oral administration, posing adherence challenges.

Purpose of the Study:

  • To evaluate the efficacy and safety of an extended-release intramuscular formulation of naltrexone for alcohol dependence.
  • To assess the impact of a 28-day sustained-release naltrexone injection on treatment adherence and drinking behavior.

Main Methods:

  • A 6-month, placebo-controlled trial involving adult patients with alcohol dependence.
  • Participants received either extended-release intramuscular naltrexone 380 mg every 4 weeks or placebo, alongside psychosocial therapy.
  • Primary endpoint was the reduction in the heavy drinking event rate.

Main Results:

  • Extended-release intramuscular naltrexone significantly reduced the heavy drinking event rate compared to placebo.
  • A subset of patients abstaining prior to treatment showed greater reductions in drinking days with active treatment.
  • The formulation was generally well-tolerated over 18 months, with infrequent serious adverse events.

Conclusions:

  • Extended-release intramuscular naltrexone is an effective and generally well-tolerated option for treating alcohol dependence.
  • The 28-day injectable formulation improves upon adherence challenges associated with daily oral naltrexone.
  • This long-acting naltrexone offers a valuable therapeutic advance in managing alcohol use disorder.

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