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Study Title and Description

A randomized controlled trial of buprenorphine taper duration among opioid-dependent adolescents and young adults.



Key Questions Addressed
1 Evidence map
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Primary Publication Information
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TitleData
Title A randomized controlled trial of buprenorphine taper duration among opioid-dependent adolescents and young adults.
Author Marsch LA., Moore SK., Borodovsky JT., Solhkhah R., Badger GJ., Semino S., Jarrett K., Condon KD., Rossettie K., Vincent P., Hajizadeh N., Ducat E.
Country Center for Technology and Behavioral Health, Dartmouth Psychiatric Research Center, Dartmouth College, Lebanon, NH, USA.
Year 2016
Numbers Pubmed ID: 26918564

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Evidence Map
Arms
Number Title Description Comments
1 Buprenorphine_Placebo_CBT_MI_Educ_Fam_CM 28-day buprenorphine taper
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2 Buprenorphine_CBT_MI_Educ_Fam_CM 56-day buprenorphine taper
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Design Details
Question... Follow Up Answer Follow-up Answer
Should this citation be included? Yes
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Does this paper originate from a primary study of interest? No
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Ages eligible (in years) 13
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24
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Total sample size (in all arms) 53
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Age distribution of enrolled population (in years) 20.5
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Substance used Opioid
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Interventions studied? Pharmacologic
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Outcome? Objective measurement of use/abstinence and/or intensity
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Self report of use/abstinence and/or intensity
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Other ... treatment retention
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Age variation of enrolled population (in years) 2.5
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Study type RCT
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Is any arm a brief intervention (or single session)? No
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Income level of country(ies) of origin ... Country(ies) name(s) Unclear ... United States
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Results & Comparisons


Results Data
P-Value
Outcome: pct abstinent for nos      Population: All Participants Between-Arm Comparisons
Time Point Measure Buprenorphine_Placebo_CBT_MI_Educ_Fam_CM Buprenorphine_CBT_MI_Educ_Fam_CM Comparison Measure Buprenorphine_Placebo_CBT_MI_Educ_Fam_CM vs. Buprenorphine_CBT_MI_Educ_Fam_CM


2 months

Percentage 17.2 34.6 0.039
CI_low 5.8 23.2
CI_high 28.6 50
N Analyzed 28 25


Quality Dimensions
Dimension Value Notes Comments
Intention-to-treat-analysis: Bias due to incomplete reporting and analysis according to group allocation Yes
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Group similarity at baseline (selection bias): Selection bias due to dissimilarity at baseline for the most important prognostic indicators No Nicotine was imbalanced, and it seems a significant factor for buprenorphine treatment.
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Co-interventions (performance bias): Performance bias because co-interventions were different across groups Yes I
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Compliance (performance bias): Performance bias due to inappropriate compliance with interventions across groups No
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Timing of outcome assessments (detection bias): Detection bias because important outcomes were not measured at the same time across groups Yes
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Additional Bias: Bias due to problems not covered elsewhere in the table. If yes, describe them in the Notes.
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Random sequence generation (selection bias): Selection bias (biased allocation to interventions) due to inadequate generation of a randomized sequence Unclear Minimization, but unclear how the sequence was generated.
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Allocation concealment (selection bias): Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment Unclear
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Blinding of participants (performance bias): Performance bias due to knowledge of the allocated interventions by participants during the study Low Even after 28 days of tapering, those in that group received identical tablets.
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Blinding of personnel/ care providers (performance bias): Performance bias due to knowledge of the allocated interventions by personnel/care providers during the study. Low
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Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. Low Objective outcome (primary) and the secondary outcomes, albeit not objective, were mostly reported by participants who were blinded.
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Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data High
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Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting
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Quality Rating
No quality rating data was found.