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[Injectable extended-release naltrexone for opioid dependence: a double-blind, placebo-controlled, multicentre
Extended-release naltrexone (XR-NTX) injections effectively treat opioid dependence post-detoxification. Combined with counseling, XR-NTX significantly improves abstinence rates compared to placebo.
Area of Science:
- Pharmacology
- Addiction Medicine
- Clinical Trials
Context:
- Opioid dependence remains a significant public health issue requiring effective long-term treatment strategies.
- Post-detoxification management is crucial to prevent relapse and support sustained recovery.
- Novel therapeutic formulations are needed to improve patient adherence and treatment outcomes.
Purpose:
- To evaluate the efficacy and safety of an extended-release injectable formulation of naltrexone (XR-NTX) for patients with opioid dependence following detoxification.
- To compare the effectiveness of XR-NTX combined with psychosocial treatment against placebo with psychosocial support over a 24-week period.
Summary:
- A 24-week, double-blind, placebo-controlled trial randomized 250 patients with opioid dependence to receive either 380 mg of XR-NTX or placebo, alongside biweekly counseling sessions.
- The primary endpoint, confirmed abstinence from week 5 to 24, was assessed via urine drug tests and self-reporting.
- Secondary endpoints included opioid-free days, craving scores, treatment retention, and relapse rates.
Impact:
- XR-NTX, when administered monthly with psychosocial support, offers a promising new pharmacological option for managing opioid dependence.
- This injectable formulation demonstrated superior efficacy in maintaining abstinence and reducing relapse compared to placebo, highlighting its potential clinical utility.
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