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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.