Open-label Study of Injectable Extended-release Naltrexone (XR-NTX) in Healthcare Professionals With Opioid Dependence

Paul H Earley, Jacqueline Zummo, Asli Memisoglu, Bernard L Silverman, David R Gastfriend, Paul H Earley, Jacqueline Zummo, Asli Memisoglu, Bernard L Silverman, David R Gastfriend

Abstract

Objectives: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Conflict of interest statement

Conflicts of interest: Dr Earley is a paid consultant to Alkermes, Inc; Drs Memisoglu and Silverman are employees of Alkermes, Inc; and Dr Gastfriend and Ms Zummo were employees of Alkermes, Inc when the study and analyses were conducted.

Figures

FIGURE 1
FIGURE 1
Retention of the HCP population (Kaplan-Meier plot) over the 24-month study period with XR-NTX treatment.
FIGURE 2
FIGURE 2
Outcomes of the HCP population over the 24-month study period with XR-NTX treatment. (A) Opioid craving scores (all subjects and completers). Total score on the opioid craving scale ranges from 1 to 7; higher scores = more craving. (B) SF-36 physical component scores (all subjects and completers). Higher scores = greater function; scores (ranging from 0 to 100) are adjusted such that 50 = normative for healthy US populations and 10 points = 1 standard deviation. (C) SF-36 mental component scores (all subjects and completers). Higher scores = greater function; scores (ranging from 0 to 100) are adjusted such that 50 = normative for healthy US populations and 10 points = 1 standard deviation. (D) TSQM global satisfaction scores (all subjects and completers). Scaled scores were derived for global satisfaction from TSQM questions assessing patient satisfaction with medication. Scores ranged from 0 to 100, with higher scores indicating greater satisfaction.
FIGURE 3
FIGURE 3
Employment status of HCPs over the 24-month study period with XR-NTX treatment. Represents employment as an HCP or otherwise.

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