Extended-Release Naltrexone to Prevent Opioid Relapse in Criminal Justice Offenders

Hannah Webb, Mercer University College of Pharmacy


It is stated that the chance for an incarcerated offender to relapse and overdose is highest upon release of prison than at any other time while in the United States criminal justice’s care. [1]


The Food and Drug Administration approved extended-release naltrexone, a sustained-release monthly injectable formulation of the full mu-opioid receptor antagonist, in 2010 for the prevention of relapse to opioid dependence. [2]


Extended-release naltrexone is a non-controlled substance with no known abuse or diversion potential. [3]

Title: Extended-Release Naltrexone to Prevent Opioid Relapse in Criminal Justice Offenders
Design Open-label, randomized, controlled effectiveness trial; N= 308
Objective To examine the effectiveness of extended-release naltrexone among community-dwelling criminal justice offenders who were at high risk for opioid relapse and related adverse outcomes
Study Groups Extended release naltrexone (n= 153); usual treatment (brief counseling and referrals for community treatment programs) (n=155)
Methods Five independently funded sites implemented a common collaborative protocol
Duration 24 weeks
Primary Outcome Measure The time (in weeks) to an opioid-relapse event during the 24-week treatment phase. A relapse event was defined as 10 or more days of opioid use in a 28-day period as assessed by self-reporting or by testing of urine samples.
Baseline Characteristics Mean age 44 years
Sex 85% male
Black or Hispanic 77%
On parole or probation 74%
Use of heroin or other opioids in last 30 days 65%
Heroin use (ever in life) 88%
Injection-drug use (ever in life) 41%
Results Outcome Extended-release naltrexone (n= 153) Usual treatment (n= 155) p value Odds ratio
Primary outcome: median time to relapse (weeks) 10.5 5.0 <0.001 0.49
Adverse Events Common Adverse Events: injection-site reaction (27.5%), headache (19%), gastrointestinal upset (18.3%), insomnia (7.2%), depression (1.3%)
Serious Adverse Events: suicidality (2%), death (1.3%), stroke (1.3%), chest pain (1.3%)
Percentage that Discontinued due to Adverse Events: 3.3%
Study Author Conclusions The prevention of opioid use by extended-release naltrexone did not persist through follow-up at week 52 and week 78, after the treatment phase had ended. In addition, the study did not detect a benefit of extended-release naltrexone on rates of cocaine, heavy alcohol, and injection drug use.


This multisite, randomized, controlled trial showed that extended-release naltrexone resulted in a lower rate of opioid relapse than the rate with usual treatment. There was no increased risk of overdose events during treatment with extended release naltrexone or immediately after its discontinuation. Clinically, naltrexone extended release has the potential to be used as an aid to help prevent opioid relapse in criminal justice offenders.



  1. Binswanger IA, Blatchford PJ, Mueller SR, Stern MF. Mortality after prison release:

opioid overdose and other causes of death, risk factors, and time trends from 1999 to 2009. Ann Intern Med 2013; 159:592-600.

  1. Naltrexone for extended-release injectable suspension Information. U.S. Food and Drug Administration. Accessed April 4, 2016 http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103334.htm

3. Lee, Joshua, Peter Friedmann, Timothy Kinlock, Edward Nunes, Tamara Boney, Randall Hoskinson, Donna Wilson, Ryan McDonald, John Rotrosen, Marc GGourevitch, and Michael Gordon. Extended-Release Naltrexone to Prevent Opioid Release in Criminal Justice Offenders. N Engld J Med 2016; 374:1232-42.


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