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Extended-release naltrexone lowers opioid relapse rates in prisoners

Among criminal justice offenders, extended-release naltrexone was associated with a lower opioid relapse rate compared with usual treatment, according to recent findings.

“We believe our study is the first of its kind to look at the real-world effectiveness of extended-release naltrexone in community settings,” Joshua D. Lee, MD, of New York University, said in a press release. “It may be particularly effective with populations, such as recently released prisoners, who typically don’t have access to other evidence-based daily medications for opiate disorders, like methadone or buprenorphine.”

To assess efficacy of extended-release naltrexone for prevention of opioid dependence relapse in U.S. criminal justice populations, researchers conducted an open-label, randomized trial across five sites. Adult criminal justice offenders received a 24-week course of extended-release naltrexone (Vivitrol, Alkermes Inc.) (n = 153) or usual treatment (n = 155), which consisted of brief counseling and referrals for community treatment programs. Study participants had a history of opioid dependence, preferred opioid-free rather than opioid maintenance treatments, and were abstinent from opioids at randomization. Post-treatment follow-up was conducted at 27, 52 and 78 weeks.

During the treatment phase, participants who received naltrexone had a longer median time to relapse than those who received usual treatment (10.5 vs. 5 weeks; HR = 0.49; 95% CI, 0.36-0.68; P < .001).

The naltrexone group also had lower relapse rates (43% vs. 64%; OR = 0.43; 95% CI, 0.28-0.65; P < .001) and higher rates of opioid-negative urine samples during the treatment phase, compared with those who received usual treatment.

At 78 weeks, approximately 1 year after treatment end, rates of opioid-negative urine samples were equal among groups, at 46%.

Charles P. O'Brien

Rates of self-reported cocaine, alcohol and IV drug use, unsafe sex and re-incarceration were not significantly lower among the naltrexone group at week 78.

Overall, there were no overdoses in the naltrexone group, compared with seven in the usual treatment group (P = .02).

“Judges and parole officers equate methadone with ‘giving in’ to the addict, giving them what they want. But, you can give it in a controlled way so that a person can function very well and does not go into withdrawal,” study researcher Charles P. O’Brien, MD, PhD, of the University of Pennsylvania, said in a press release. “If someone is scheduled to get out of prison with a history of opioid addiction you could give them one injection and, at least for the next month, they cannot relapse. Normally, they relapse the same day.” – by Amanda Oldt

Disclosure: Lee reports receiving grant support and study medication from Alkermes and study medication from Indivior (formerly Reckitt Benckiser). Please see the full study for a list of all authors’ relevant financial disclosures.