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Journal Club

This study compares the effectiveness of 6-month buprenorphine implants with sublingual buprenorphine in treating opioid use disorder in abstinent adults. The results show that buprenorphine implants are non-inferior to sublingual buprenorphine in reducing illicit opioid use.

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Journal Club

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  1. Journal Club Alcohol, Other Drugs, and Health: Current Evidence September-October, 2016

  2. Featured Article Effect of buprenorphine implants on illicit opioid use among abstinent adults with opioid dependence treated with sublingual buprenorphine: a randomized clinical trial. Rosenthal RN, et al. JAMA. 2016;316(3):282–290.

  3. Study Objectives • To determine the non-inferiority of 6-month buprenorphine implants compared with sublingual buprenorphine for the treatment of opioid use disorder among patients with DSM-IV opioid dependence who are currently receiving 8 mg or less of buprenorphine with abstinence for greater than 90 days. www.aodhealth.org

  4. Study Design • Randomized, active-controlled, 24-week, double-blind, double-dummy study among 117 participants receiving treatment at 21 office-based buprenorphine outpatient treatment sites. • Patients randomized to receive sublingual buprenorphine plus 4 placebo implants or sublingual placebo plus four 80-mg buprenorphine hydrochloride implants. www.aodhealth.org

  5. 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

  6. 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

  7. 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

  8. Were patients randomized? • Yes. • Participants were randomized in a 1:1 ratio within a block size of 4 using a computerized system without stratification. www.aodhealth.org

  9. Was randomization concealed? • Yes. • The study was double-blinded. www.aodhealth.org

  10. Were patients analyzed in the groups to which they were randomized? • Yes. www.aodhealth.org

  11. Were the patients in the treatment and control groups similar? • Yes. The characteristics of the groups at baseline were similar. www.aodhealth.org

  12. Were patients aware of group allocation? • No, patients were blinded to group allocation. www.aodhealth.org

  13. Were clinicians aware of group allocation? • No, clinicians were blinded to group allocation. • “staff involved in implant insertion and removal at 6 months did not participate in study evaluation as active and placebo implants varied slightly in appearance.” www.aodhealth.org

  14. Were outcome assessors aware of group allocation? • No. www.aodhealth.org

  15. Was follow-up complete? • 81/87 (93%) randomized to receive buprenorphine implant completed follow-up • 84/90 (93%) randomized to receive sublingual buprenorphine completed follow-up www.aodhealth.org

  16. What Are the Results? • How large was the treatment effect? • How precise was the estimate of the treatment effect? www.aodhealth.org

  17. How large and precise was the treatment effect? • Primary endpoint was proportion of responders. Responders were defined as those with > 4 of 6 months without opioid-positive urine test result and self-report • Responder rates for the intention-to-treat population: • Implant group (81/84, 96%) • Sublingual group (78/89, 88%) • Difference: 8.8% (95% CI, 0.009 to ∞) www.aodhealth.org 17

  18. 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

  19. Were the study patients similar to those in my practice? • “…the majority of the participants enrolled were white, employed, with at least a high school education, and dependent on prescription opioids” • Participants… • had DSM-IV opioid dependence • were aged 18 to 65 years • received sublingual buprenorphine for at least 24 weeks as an outpatient at a stable dosage of ≤8 mg/d • showed no evidence of opioid withdrawal or illicit opioid-positive urine samples for ≥90 days prior to study entry • Female participants of childbearing potential agreed to use contraception during the study. www.aodhealth.org

  20. Were all clinically important outcomes considered? • No mention of patient satisfaction. www.aodhealth.org

  21. Are the likely treatment benefits worth the potential harm and costs? • Serious adverse events occurred in 5 participants, 3 in the sub-lingual buprenorphine group and 2 in the buprenorphine implant group. • 23% of buprenorphine implant patients vs. 14% of sub-lingual buprenorphine patients had > implant site related adverse event • Costs were not reported. www.aodhealth.org

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