Journal Club Alcohol, Other Drugs, and Health: Current Evidence May-June, 2016
Featured Article Extended-Release Naltrexone to Prevent Opioid Relapse in Criminal Justice Offenders. Lee JD, et al. N Engl J Med. 2016; 374(13): 1232– 1242.
Study Objectives • To examine a 24 -week course of extendedrelease naltrexone, compared with usual care, to determine impact on return to opioid use among adults involved in the US criminal justice system. www. aodhealth. org 3
Study Design • Randomized, open-label trial across five sites for 24 weeks. • 153 participants received extended-release naltrexone. • 155 participants received usual care to prevent return to opioid use (brief counseling and referrals for community treatment programs). www. aodhealth. org 4
Assessing Validity of an Article about Therapy • Are the results valid? • What are the results? • How can I apply the results to patient care? www. aodhealth. org 5
Are the Results Valid? • Were patients randomized? • Was randomization concealed? • Were patients analyzed in the groups to which they were randomized? • Were patients in the treatment and control groups similar with respect to known prognostic variables? www. aodhealth. org 6
Are the Results Valid? (cont‘d) • Were patients aware of group allocation? • Were clinicians aware of group allocation? • Were outcome assessors aware of group allocation? • Was follow-up complete? www. aodhealth. org 7
Were patients randomized? • Yes. – Participants were randomized in a 1: 1 ratio using an urn randomization procedure. www. aodhealth. org 8
Was randomization concealed? • Yes. – “An independent, centralized, automated telephone system made the treatment assignments. ” www. aodhealth. org 9
Were patients analyzed in the groups to which they were randomized? • Yes. www. aodhealth. org 10
Were the patients in the treatment and control groups similar? • Yes. The characteristics of the groups at baseline were similar. www. aodhealth. org 11
Were patients aware of group allocation? • Yes, patients were aware of group allocation based on treatment received. www. aodhealth. org 12
Were clinicians aware of group allocation? • Yes. www. aodhealth. org 13
Were outcome assessors aware of group allocation? • Yes. www. aodhealth. org 14
Was follow-up complete? • 119/153 (78%) randomized to receive extended-release naltrexone completed follow up at 24 weeks • 126/155 (81%) randomized to receive 155 participants received usual care completed follow up at 24 weeks www. aodhealth. org 15
What Are the Results? • How large was the treatment effect? • How precise was the estimate of the treatment effect? www. aodhealth. org 16
How large and precise was the treatment effect? • During the 24 -week treatment phase, participants assigned to extended-release naltrexone had a longer median time to return to ≥ 10 days of opioid use (10. 5 versus 5 weeks; hazard ratio, 0. 49; 95% confidence interval [CI], 0. 36 -0. 68), a lower rate of return to such use (43% versus 64%; odds ratio, 0. 43; 95% CI, 0. 28 -0. 65), and a higher rate of opioid-negative urine samples (74% versus 56%; odds ratio, 2. 30; 95% CI, 1. 48 -3. 54), compared with usual care. • Compared with the extended-release naltrexone group, more participants in the usual care group pursued opioid agonist treatment (OAT) during the trial (11% versus 37%), primarily after returning to opioid use. • There were no overdose events reported in the extended-release naltrexone group and 7 (3 fatal) in the usual care group. www. aodhealth. org 17
How Can I Apply the Results to Patient Care? • Were the study patients similar to the patients in my practice? • Were all clinically important outcomes considered? • Are the likely treatment benefits worth the potential harm and costs? www. aodhealth. org 18
Were the study patients similar to those in my practice? • The trial was conducted across five sites in the US among people involved with the criminal justice system. • At baseline, participants preferred non-OAT approaches to treatment. • The mean age of participants was 44 years. They were: – – 85% 77% 74% 65% male black or Hispanic were on parole or probation had not used heroin or other opioids in the previous 30 days www. aodhealth. org 19
Were all clinically important outcomes considered? • Yes. www. aodhealth. org 20
Are the likely treatment benefits worth the potential harm and costs? • Costs were not reported. www. aodhealth. org 21
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