BACKGROUND:
Extended-release
naltrexone, a sustained-release monthly injectable formulation of the full
mu-opioid receptor antagonist, is effective for the prevention of relapse to
opioid dependence. Data supporting its effectiveness in U.S. criminal justice
populations are limited.
METHODS:
In this
five-site, open-label, randomized trial, we compared a 24-week course of
extended-release naltrexone (Vivitrol) with usual treatment, consisting of
brief counseling and referrals for community treatment programs, for the prevention
of opioid relapse among adult criminal justice offenders (i.e., persons
involved in the U.S. criminal justice system) who had a history of opioid
dependence and a preference for opioid-free rather than opioid maintenance
treatments and who were abstinent from opioids at the time of randomization.
The primary outcome was the time to an opioid-relapse event, which was defined
as 10 or more days of opioid use in a 28-day period as assessed by self-report
or by testing of urine samples obtained every 2 weeks; a positive or missing
sample was computed as 5 days of opioid use. Post-treatment follow-up occurred
at weeks 27, 52, and 78.
RESULTS:
A total
of 153 participants were assigned to extended-release naltrexone and 155 to
usual treatment. During the 24-week treatment phase, participants assigned to
extended-release naltrexone had a longer median time to relapse than did those
assigned to usual treatment (10.5 vs. 5.0 weeks, P<0.001; hazard ratio,
0.49; 95% confidence interval [CI], 0.36 to 0.68), a lower rate of relapse (43%
vs. 64% of participants, P<0.001; odds ratio, 0.43; 95% CI, 0.28 to 0.65),
and a higher rate of opioid-negative urine samples (74% vs. 56%, P<0.001;
odds ratio, 2.30; 95% CI, 1.48 to 3.54). At week 78 (approximately 1 year after
the end of the treatment phase), rates of opioid-negative urine samples were
equal (46% in each group, P=0.91). The rates of other prespecified secondary
outcome measures--self-reported cocaine, alcohol, and intravenous drug use,
unsafe sex, and reincarceration--were not significantly lower with
extended-release naltrexone than with usual treatment. Over the total 78 weeks
observed, there were no overdose events in the extended-release naltrexone
group and seven in the usual-treatment group (P=0.02).
CONCLUSIONS:
In this trial involving criminal justice offenders,
extended-release naltrexone was associated with a rate of opioid relapse that
was lower than that with usual treatment. Opioid-use prevention effects waned
after treatment discontinuation.
By: Lee JD1, Friedmann PD1, Kinlock TW1, Nunes EV1, Boney TY1, Hoskinson RA Jr1, Wilson D1, McDonald R1, Rotrosen J1, Gourevitch MN1, Gordon M1,Fishman M1, Chen DT1, Bonnie RJ1, Cornish JW1, Murphy SM1, O'Brien CP1.
- 1From the Departments of Population Health (J.D.L., R.M., M.N.G.), Medicine, Division of General Internal Medicine and Clinical Innovation (J.D.L.), and Psychiatry (J.R.), New York University, and the New York State Psychiatric Institute, Columbia University College of Physicians and Surgeons (E.V.N.) - both in New York; the Division of General Internal Medicine, the Department of Medicine, Rhode Island Hospital and Alpert Medical School of Brown University, Providence (P.D.F., R.A.H., D.W.); Friends Research Institute (T.W.K., M.G., M.F.), the University of Baltimore, School of Criminal Justice (T.W.K.), and Maryland Treatment Centers (M.F.) - all in Baltimore; the University of Pennsylvania (T.Y.B., J.W.C., C.P.O.) and the Philadelphia Veterans Affairs Medical Center (J.W.C.) - both in Philadelphia; the Center for Biomedical Ethics and Humanities, School of Medicine (D.T.C.) and the School of Law (R.J.B.), University of Virginia, Charlottesville; and Washington State University, Spokane (S.M.M.).
- N Engl J Med. 2016 Mar 31;374(13):1232-42. doi: 10.1056/NEJMoa1505409.
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