title: Open-label Study of Injectable Extended-release Naltrexone (XR-NTX) in Healthcare Professionals With Opioid Dependence.
abstract: Healthcare professionals (HCPs) with opioid dependence are at risk for relapse and death, particularly in the first year of recovery; however, maintenance treatment with opioid agonists is controversial in this safety-sensitive group. We evaluated long-term safety, tolerability, and treatment outcomes of injectable, intramuscular, extended-release naltrexone (XR-NTX) in opioid-dependent HCPs.
  
  
  
  This single-arm, multisite, open-label study was conducted in opioid-dependent HCPs who had been detoxified from opioids for at least 2 weeks. Subjects received monthly XR-NTX injections for up to 24 months, combined with counseling via intensive outpatient substance abuse treatment programs. Assessments included monthly urine opioid drug tests and routine safety assessments, along with a trimonthly short form (36) Health Survey, opioid craving questionnaire, and Treatment Satisfaction Questionnaire for Medication.
  
  
  
  Of 49 opioid-dependent HCPs screened, 38 enrolled and received at least 1 XR-NTX injection. Most were female (n = 31) and nurses or nursing assistants (n = 30). More than half (n = 21; 55.3%) received at least 12 injections. Seven discontinued due to adverse events (3 anxiety, 2 headache, 1 injection-site mass, 1 derealization). None experienced relapses to opioid dependence necessitating detoxification, overdose, or death during treatment. At 24 months, mean opioid craving fell by 45.2%, and short form (36) mental component scores improved by 31.1% from baseline and approached normal levels. Of 22 unemployed subjects at baseline, 45.5% improved employment status at 24 months.
  
  
  
  Long-term (2 years) XR-NTX was associated with no new safety concerns, and, compared with shorter-term studies in the general population, similar or better rates of retention, opioid-negative urines, opioid craving reduction, mental health functional quality of life improvement, and re-employment.
authors.affiliation: Earley Consultancy, LLC, Atlanta, GA (PHE); Alkermes, Inc, Waltham, MA (JZ, AM, BLS); Treatment Research Institute, Philadelphia, PA (DRG).
authors.forename: Paul H
authors.initials: PH
authors.lastname: Earley
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Zummo
authors.forename: Asli
authors.initials: A
authors.lastname: Memisoglu
authors.forename: Bernard L
authors.initials: BL
authors.lastname: Silverman
authors.forename: David R
authors.initials: DR
authors.lastname: Gastfriend
mesh_terms: D000328:Adult; D003692:Delayed-Action Preparations; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006282:Health Personnel; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D009271:Naltrexone / Q000008:administration & dosage* / Q000627:therapeutic use; D009292:Narcotic Antagonists / Q000008:administration & dosage* / Q000627:therapeutic use; D009784:Occupational Diseases / Q000188:drug therapy*; D009293:Opioid-Related Disorders / Q000188:drug therapy*; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D003692:Delayed-Action Preparations; D009292:Narcotic Antagonists; D009271:Naltrexone