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Open-label Study of Injectable Extended-release Naltrexone (XR-NTX) in Healthcare Professionals With Opioid
Paul H Earley1, Jacqueline Zummo, Asli Memisoglu
1Earley Consultancy, LLC, Atlanta, GA (PHE); Alkermes, Inc, Waltham, MA (JZ, AM, BLS); Treatment Research Institute, Philadelphia, PA (DRG).
Journal of Addiction Medicine
|March 31, 2017
Summary
Long-term injectable extended-release naltrexone (XR-NTX) is safe and effective for healthcare professionals with opioid dependence. This treatment reduced opioid craving and improved mental health, supporting sustained recovery.
Area of Science:
- Addiction Medicine
- Pharmacology
- Healthcare Professional Well-being
Background:
- Opioid dependence poses significant risks for healthcare professionals (HCPs), including relapse and mortality, especially within the first year of recovery.
- Maintenance treatment with opioid agonists is controversial for this safety-sensitive population.
- Extended-release naltrexone (XR-NTX) offers a potential alternative for managing opioid dependence in HCPs.
Purpose of the Study:
- To evaluate the long-term safety and tolerability of injectable, intramuscular, extended-release naltrexone (XR-NTX).
- To assess treatment outcomes, including relapse rates, craving, and quality of life, in opioid-dependent healthcare professionals.
- To determine the efficacy of XR-NTX in supporting sustained recovery among HCPs.
Main Methods:
- A single-arm, multisite, open-label study involving opioid-dependent HCPs who had undergone at least 2 weeks of detoxification.
- Participants received monthly XR-NTX injections for up to 24 months, complemented by intensive outpatient substance abuse treatment and counseling.
- Assessments included monthly urine drug tests, safety evaluations, and validated questionnaires for health status, craving, and treatment satisfaction.
Main Results:
- Of 38 enrolled HCPs, over half (55.3%) completed at least 12 injections; 7 discontinued due to adverse events.
- No participants experienced relapse, overdose, or death during treatment.
- Significant improvements were observed: 45.2% reduction in opioid craving, 31.1% improvement in mental health scores, and improved employment status in 45.5% of initially unemployed subjects.
Conclusions:
- Long-term (2-year) XR-NTX treatment demonstrated a favorable safety profile in opioid-dependent HCPs, with no new safety concerns identified.
- Treatment outcomes, including retention, opioid-negative urines, craving reduction, and quality of life, were comparable or superior to shorter-term studies in the general population.
- XR-NTX is a viable long-term treatment option for HCPs with opioid dependence, supporting recovery and re-employment.