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Journal Club

Journal Club. Alcohol, Other Drugs, and Health: Current Evidence November –December 2011. Featured Article. Adjunctive Counseling during Brief and Extended Buprenorphine-Naloxone Treatment for Prescription Opioid Dependence. Weiss RD, et al. Arch Gen Psychiatry. 2011;68(12):1238–1246.

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Journal Club

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  1. Journal Club Alcohol, Other Drugs, and Health: Current Evidence November–December 2011 www.aodhealth.org

  2. Featured Article Adjunctive Counseling during Brief and Extended Buprenorphine-Naloxone Treatment for Prescription Opioid Dependence Weiss RD, et al. Arch Gen Psychiatry. 2011;68(12):1238–1246. www.aodhealth.org

  3. Study Objective • To evaluate the efficacy of brief and extended buprenorphine/naloxone (BUP/NX) treatment, with different counseling intensities, among patients with prescription-opioid dependence. www.aodhealth.org

  4. Study Design • Ten-site US randomized clinical trial with a 2-phase adaptive treatment research design: • Phase 1: Brief treatment (2-week BUP/NX stabilization followed by 2-week taper and 8-week postmedication follow-up). • Phase 2: Patients without successful opioid use outcomes* after phase 1 received extended (12-week) BUP/NX treatment followed by 4-week taper and 8-week postmedication follow-up. • The sample included 653 treatment-seeking outpatients with prescription opioid dependence randomized to either standard medical management (SMM) or SMM plus opioid dependence counseling. *Minimal or no opioid use based on self-report and confirmed by urine testing. 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. • Randomization was stratified in phase 1 by 2 prognostic variables: 1) any history of heroin use and 2) chronic pain at baseline. • Patients continuing to phase 2 were stratified by phase 1 treatment assignment (SMM or SMM plus counseling). www.aodhealth.org

  9. Was randomization concealed? • Yes, using a permuted block design. www.aodhealth.org

  10. Were patients analyzed in the groups to which they were randomized? • Yes (intention-to-treat analysis). www.aodhealth.org

  11. Were the patients in the treatment and control groups similar? • Yes. • Sociodemographic and clinical characteristics were similar between treatment groups. www.aodhealth.org

  12. Were patients aware of group allocation? • Yes. www.aodhealth.org

  13. Were clinicians aware of group allocation? • Yes. www.aodhealth.org

  14. Were outcome assessors aware of group allocation? • Unknown (outcome-assessor awareness of group assignment is not discussed). www.aodhealth.org

  15. Was follow-up complete? • No. • The drop-out rate from phase 1 to phase 2 was 38% (251 of 653 patients); however, drop-out rates were similar between groups (111 in the SMM group and 139 in the SMM + counseling group). 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 was the treatment effect? • In phase 1, 6.6% of patients (43 of 653) had successful outcomes. • In phase 2, 49.2% of patients (177 of 360) had successful outcomes during extended BUP/NX treatment (week 12). • Success rates dropped to 8.6% (31 of 360 patients) 8 weeks after completing the BUP/NX taper (phase 2, week 24). • In secondary analyses, successful phase-2 outcomes were more common while taking BUP/NX than 8 weeks after taper (49.2% versus 8.6%, respectively [p<.001]). • Outcomes did not differ between the SMM and the SMM plus counseling groups at any time point. www.aodhealth.org

  18. How precise was the estimate of the treatment effect? *Generalized estimating equation. **Reference category = SMM+ODC. †Adjusted for chronic pain at baseline and lifetime history of heroin use. ‡Adjusted for chronic pain at baseline, lifetime history of heroin use, and phase 1 randomization. www.aodhealth.org

  19. 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

  20. Were the study patients similar to those in my practice? • Participants were adults (mean age, 33 years) seeking treatment for prescription-opioid dependence. Forty percent were women, and 91% were white. www.aodhealth.org

  21. Were all clinically important outcomes considered? • Yes. • The presence of chronic pain at baseline did not affect opioid use outcomes. • A history of ever using heroin was associated with lower phase-2 success rates while taking BUP/NX. www.aodhealth.org

  22. Are the likely treatment benefits worth the potential harm and costs? • Harms or costs were not assessed in this trial. www.aodhealth.org

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