BACKGROUND AND AIMS: Relapse to addiction following incarceration is common. We estimated the feasibility and effectiveness of extended-release naltrexone (XR-NTX) as relapse prevention among opioid dependent male adults leaving a large urban jail.
DESIGN: 8-week, proof-of-concept, open-label, non-blinded randomized effectiveness trial.
SETTING: New York City jails and Bellevue Hospital Center Adult Primary Care clinics, USA.
PARTICIPANTS: From Jan 2010 to July 2013, 34 opioid dependent adult males with no interest in agonist treatments (methadone, buprenorphine) received a counseling and referral intervention and were randomized to XR-NTX (n = 17) vs. no medication (n = 17) within a week of jail release.
INTERVENTION: XR-NTX(Vivitrol(R); Alkermes Inc.), a long-acting injectable mu opioid receptor antagonist.
MEASURES: The primary intent-to-treat outcome was post-release opioid relapse at week 4, defined as >10 days of opioid misuse by self-report and urine toxicologies. Secondary outcomes were proportion of urine samples negative for opioids and rates of opioid abstinence, intravenous drug use (IVDU), cocaine use, community treatment participation, re-incarceration, and overdose.
FINDINGS: Acceptance of XR-NTX was high; 15 of 17 initiated treatment. Rates of the primary outcome of week 4 opioid relapse were lower among XR-NTX participants: 38% vs. 88% (p < 0.004; Odds Ratio 0.08 [95% CI, 0.01-0.48]); more XR-NTX urine samples were negative for opioids, 59% vs. 24% (p < 0.009; OR 3.5 [95%CI, 1.4-8.5]). There were no significant differences in the remaining secondary outcomes, including rates of IVDU, cocaine use, re-incarceration, and overdose.
CONCLUSION: Extended-release naltrexone is associated with significantly lower rates of opioid relapse among men in the USA following release from jail when compared with a no medication treatment-as-usual condition.
Opioid treatment at release from jail using extended-release naltrexone: A pilot proof-of-concept randomized effectiveness trial
Addiction, 110 (6), 1008-1014. doi: 10.1111/add.12894.