Www.aodhealth.org1 Journal Club Alcohol, Other Drugs, and Health: Current Evidence November–December 2008.
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www.aodhealth.org1 Journal Club Alcohol, Other Drugs, and Health: Current Evidence November–December 2008
www.aodhealth.org2 Featured Article Extended vs Short-term Buprenorphine-Naloxone for Treatment of Opioid-Addicted Youth Woody GE, et al. JAMA. 2008;300(17):2003–2011.
www.aodhealth.org3 Study Objective Evaluate the efficacy of a 2 week versus a 12 week taper of buprenorphine-naloxone for opioid dependent youth.
www.aodhealth.org4 Study Design Randomized trial including 152 opioid dependent youth (mean age, 19 years) seeking treatment at 6 community drug-treatment programs across the US. Patients were assigned to either: –12 weeks of buprenorphine-naloxone (up to 24 mg per day tapered from week 9 to week 12), or –2 weeks of buprenorphine-naloxone (up to 14 mg per day of buprenorphine-naloxone tapered to end by day 14) All were offered weekly individual and group counseling.
www.aodhealth.org5 Study Design - II The primary outcome measure was opioid-positive urine test results at weeks 4, 8, and 12. Secondary outcome measures were: –dropout from the assigned condition, –enrollment in addiction treatment outside the assigned condition, –other drug use, and –adverse events.
www.aodhealth.org6 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.org7 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.org8 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.org9 Were patients randomized? Yes. –Patients were randomized separately by site. –Biased-coin randomization protected against imbalance of sex, ethnicity, route of administration, and age across treatment groups.
www.aodhealth.org10 Was randomization concealed? Yes. –Randomization was conducted by an automated service.
www.aodhealth.org11 Were patients analyzed in the groups to which they were randomized? Yes. –Patients were analyzed in the groups to which they were randomized.
www.aodhealth.org12 Were the patients in the treatment and control groups similar? Yes. –No between-group differences were observed for the following variables: sex (p=.68) race white/nonwhite (p=.65) injecting/not injecting (p=.93) age under 18 y/18–21 y (p=.78)
www.aodhealth.org13 Were patients aware of group allocation? Yes. –Patients were aware of group allocation.
www.aodhealth.org14 Were clinicians aware of group allocation? Yes. –Clinicians were aware of group allocation.
www.aodhealth.org15 Were outcome assessors aware of group allocation? Yes. –Evaluators were likely aware of group assignments because the study was not blinded. –However, assessments were objective (e.g., urine tests, dropout) and so less likely to be influenced by bias.
www.aodhealth.org16 Was follow-up complete? Sixteen of 78 two-week taper patients and 52 of 74 twelve-week patients completed the trial. Time in Trial Retention rate (percent [95% CI]) 2-week taper group (n=78) 12-week taper group (n=74) 4 weeks45 (34–56)84 (75–93) 8 weeks27 (17–37)74 (64–84) 12 weeks21 (12–30)70 (59–81) A pattern-mixture model was used to assess the impact of missing data on urine test results.
www.aodhealth.org17 What Are the Results? How large was the treatment effect? How precise was the estimate of the treatment effect?
www.aodhealth.org18 How large was the treatment effect? Percent with opioid-positive urines percent [95% CI] 2-week taper group 12-week taper group 4 weeks61% (47–75%)26% (14–38%) 8 weeks54% (38–70%)23% (11–35%) 12 weeks52% (35–67%)43 (29–57%)
www.aodhealth.org19 How precise was the estimate of the treatment effect? The 95% confidence intervals were wide but demonstrated a difference in treatment effect at 4 and 8 weeks in the primary outcomes.
www.aodhealth.org20 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.org21 Were the study patients similar to those in my practice? All patients were adolescents or young adults. Seventy-four percent were white, 25% were Hispanic, and only 2% were African American. Patients with medical or psychiatric conditions likely to make participation difficult or unsafe, who abused alcohol or sedatives in the previous 28 days, or who were pregnant/breastfeeding were excluded.
www.aodhealth.org22 Were all clinically important outcomes considered? Yes. –Primary and secondary outcomes included opioid- positive urine test results, dropout, self-reported opioid use, other drug use, injecting, enrollment in treatment outside the assigned condition, and adverse events.
www.aodhealth.org23 Are the likely treatment benefits worth the potential harm and costs? Unfortunately a formal cost-benefit analysis was not included in the report. Prior cost-benefit analyses of buprenorphine maintenance have demonstrated acceptable cost to benefit ratios.