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Study Title and Description

Extended vs short-term buprenorphine-naloxone for treatment of opioid-addicted youth: a randomized trial.



Key Questions Addressed
1 Evidence map
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Primary Publication Information
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TitleData
Title Extended vs short-term buprenorphine-naloxone for treatment of opioid-addicted youth: a randomized trial.
Author Woody GE., Poole SA., Subramaniam G., Dugosh K., Bogenschutz M., Abbott P., Patkar A., Publicker M., McCain K., Potter JS., Forman R., Vetter V., McNicholas L., Blaine J., Lynch KG., Fudala P.
Country Department of Psychiatry, Treatment Research Institute, University of Pennsylvania, 150 S Independence Mall W, Ste 600, Philadelphia, PA 19106, USA. woody@tresearch.org
Year 2008
Numbers Pubmed ID: 18984887

Secondary Publication Information
UI Title Author Country Year
Effects of buprenorphine and hepatitis C on liver enzymes in adolescents and young adults. Bogenschutz MP., Abbott PJ., Kushner R., Tonigan JS., Woody GE. Dept. of Psychiatry, University of New Mexico School of Medicine, MSC09 5030, 1 University of New Mexico, Albuquerque, NM, 87131-0001, USA. 2010
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Predictors of buprenorphine-naloxone dosing in a 12-week treatment trial for opioid-dependent youth: secondary analyses from a NIDA Clinical Trials Network study. Chakrabarti A., Woody GE., Griffin ML., Subramaniam G., Weiss RD. Division of Alcohol & Drug Abuse, McLean Hospital, Belmont, MA 02478, USA. 2010
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Association of cannabis use with opioid outcomes among opioid-dependent youth. Hill KP., Bennett HE., Griffin ML., Connery HS., Fitzmaurice GM., Subramaniam G., Woody GE., Weiss RD. Division of Alcohol and Drug Abuse, McLean Hospital, Belmont, MA 02478, United States. khill@mclean.harvard.edu 2013
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HIV risk behavior in treatment-seeking opioid-dependent youth: results from a NIDA clinical trials network multisite study. Meade CS., Weiss RD., Fitzmaurice GM., Poole SA., Subramaniam GA., Patkar AA., Connery HS., Woody GE. Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA. christina.meade@duke.edu 2010
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Presence or Absence of QTc Prolongation in Buprenorphine-Naloxone Among Youth With Opioid Dependence. Poole SA., Pecoraro A., Subramaniam G., Woody G., Vetter VL. Perelman School of Medicine at the University of Pennsylvania (SAP, AP, GW); The Children's Hospital of Philadelphia, Philadelphia, PA (VLV); Deputy Director, The Center for Clinical Trials Network, National Institute on Drug Abuse (G.S.). -- Not Found --
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Predictors of abstinence: National Institute of Drug Abuse multisite buprenorphine/naloxone treatment trial in opioid-dependent youth. Subramaniam GA., Warden D., Minhajuddin A., Fishman MJ., Stitzer ML., Adinoff B., Trivedi M., Weiss R., Potter J., Poole SA., Woody GE. National Institute on Drug Abuse, Bethesda, MD 20892, USA. geetha.subramaniam@nih.gov 2011
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Concordance between self-report and urine drug screen data in adolescent opioid dependent clinical trial participants. Wilcox CE., Bogenschutz MP., Nakazawa M., Woody G. University of New Mexico Department of Psychiatry, Albuquerque, NM 87131, USA. cewilcox@salud.unm.edu 2013
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Extraction Form: Evidence Map
Arms
Number Title Description Comments
1 Buprenorphine_Naloxone-short_TAU Short-term buprenorphine-naloxone
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2 Buprenorphine_Naloxone-extended_TAU Extended buprenorphine-naloxone
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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) 15
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21
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Total sample size (in all arms) 152
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Age distribution of enrolled population (in years) 19.2
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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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Age variation of enrolled population (in years) 1.6
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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

No Results found.

Quality Dimensions
Dimension Value Notes Comments
Intention-to-treat-analysis: Bias due to incomplete reporting and analysis according to group allocation Yes Per flow diagram
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Group similarity at baseline (selection bias): Selection bias due to dissimilarity at baseline for the most important prognostic indicators Yes
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Co-interventions (performance bias): Performance bias because co-interventions were different across groups No 29% vs. 5% enrolled in another treatment
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Compliance (performance bias): Performance bias due to inappropriate compliance with interventions across groups No 31% nonadherent (unequal between groups)
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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 Same
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Additional Bias: Bias due to problems not covered elsewhere in the table. If yes, describe them in the Notes. No
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Random sequence generation (selection bias): Selection bias (biased allocation to interventions) due to inadequate generation of a randomized sequence Low
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Allocation concealment (selection bias): Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment Low
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Blinding of participants (performance bias): Performance bias due to knowledge of the allocated interventions by participants during the study High
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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. High
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Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. High
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Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data High 55% withdrew (unequal between groups)
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Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting need to check NCT00078130: Opiate abstinence
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Quality Rating
No quality rating data was found.