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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. - PowerPoint PPT PresentationTRANSCRIPT
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Journal Club
Alcohol, Other Drugs, and Health: Current Evidence
November–December 2011
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Featured Article
Adjunctive Counseling during Brief and ExtendedBuprenorphine-Naloxone Treatment for Prescription
Opioid Dependence
Weiss RD, et al. Arch Gen Psychiatry. 2011;68(12):1238–1246.
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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.
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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.
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Assessing Validity of an Article about Therapy
• Are the results valid?
• What are the results?
• How can I apply the results to patient care?
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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?
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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?
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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).
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Was randomization concealed?
• Yes, using a permuted block design.
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Were patients analyzed in the groups to which they were
randomized?
• Yes (intention-to-treat analysis).
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Were the patients in the treatment
and control groups similar?• Yes.
– Sociodemographic and clinical characteristics were similar between treatment groups.
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Were patients aware of group allocation?
• Yes.
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Were clinicians aware of group allocation?
• Yes.
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Were outcome assessors aware of group allocation?
• Unknown (outcome-assessor awareness of group assignment is not discussed).
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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).
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What Are the Results?
• How large was the treatment effect?
• How precise was the estimate of the treatment effect?
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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.
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How precise was the estimate of the treatment
effect?Successful Opioid Use Outcome by Counseling Condition
Observed, No./Total No. (%) [95% CI]
GEE* Model–Based Results
Time point SMMSMM +
counselingOR (95% CI)** p Value
End of phase 124/324 (7.4) [4.8-10.8]
19/329 (5.8) [3.5-8.9]
1.3 (0.7-2.4)† 0.36
Phase 2, end of treatment
84/180 (46.7) [39.2-54.2]
93/180 (51.7) [44.1-59.2]
0.8 (0.5-1.2)‡ 0.27
Phase 2, 8-week follow-up
13/180 (7.2) [3.9-12.0]
18/180 (10.0) [6.0-15.3]
0.7 (0.3-1.3)‡ 0.22
*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.
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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?
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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.
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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.
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Are the likely treatment benefits worth the potential harm and
costs?
• Harms or costs were not assessed in this trial.