Transcript Related Journal Club Presentation

Journal Club
Alcohol, Other Drugs, and Health: Current Evidence
November–December 2008
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Featured Article
Extended vs Short-term
Buprenorphine-Naloxone
for Treatment of
Opioid-Addicted Youth
Woody GE, et al. JAMA. 2008;300(17):2003–2011.
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Study Objective
• Evaluate the efficacy of a 2 week versus a
12 week taper of buprenorphine-naloxone
for opioid dependent youth.
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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.
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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.
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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.
– Patients were randomized separately by
site.
– Biased-coin randomization protected
against imbalance of sex, ethnicity, route of
administration, and age across treatment
groups.
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Was randomization concealed?
• Yes.
– Randomization was conducted by an
automated service.
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Were patients analyzed in the groups
to which they were randomized?
• Yes.
– Patients were analyzed in the groups to
which they were randomized.
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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)
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Were patients aware of group
allocation?
• Yes.
– Patients were aware of group allocation.
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Were clinicians aware of group
allocation?
• Yes.
– Clinicians were aware of group allocation.
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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.
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Was follow-up complete?
• Sixteen of 78 two-week taper patients and 52 of 74
twelve-week patients completed the trial.
Retention rate (percent [95% CI])
2-week
taper
group
(n=78)
12-week
taper group (n=74)
4 weeks
45 (34–56)
84 (75–93)
8 weeks
27 (17–37)
74 (64–84)
12 weeks
21 (12–30)
70 (59–81)
Time
in Trial
• A pattern-mixture model was used to assess the impact
of missing data on urine test results.
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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?
percent [95% CI]
Percent with
opioid-positive
urines
2-week
taper
group
12-week
taper group
4 weeks
61% (47–75%)
26% (14–38%)
8 weeks
54% (38–70%)
23% (11–35%)
12 weeks
52% (35–67%)
43 (29–57%)
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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.
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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?
• 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.
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Were all clinically important
outcomes considered?
• Yes.
– Primary and secondary outcomes included opioidpositive urine test results, dropout, self-reported
opioid use, other drug use, injecting, enrollment in
treatment outside the assigned condition, and
adverse events.
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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.
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