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Study Title and Description

Memantine improves buprenorphine/naloxone treatment for opioid dependent young adults.



Key Questions Addressed
1 Evidence map
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Primary Publication Information
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TitleData
Title Memantine improves buprenorphine/naloxone treatment for opioid dependent young adults.
Author Gonzalez G., DiGirolamo G., Romero-Gonzalez M., Smelson D., Ziedonis D., Kolodziej M.
Country Division of Addiction Psychiatry, University of Massachusetts Medical School, USA; VA Central Western Massachusetts Healthcare System, USA; MAYU of New England, USA. Electronic address: gerardo.gonzalez@umassmed.edu.
Year 2015
Numbers Pubmed ID: 26454835

Secondary Publication Information
UI Title Author Country Year
Memantine-enhanced Buprenorphine Treatment for Opioid-dependent Young Adults Gonzalez 2015
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Extraction Form: Evidence Map
Arms
Number Title Description Comments
1 Buprenorphine-Naloxone_Memantine15_CBT buprenorphine–naloxone + memantine 15 mg/day + CBT
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2 Buprenorphine-Naloxone_Memantine30_CBT buprenorphine–naloxone + memantine 30 mg/day + CBT
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3 Buprenorphine-Naloxone_Placebo_CBT buprenorphine–naloxone + placebo + CBT
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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) 18
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25
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Total sample size (in all arms) 87
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Age distribution of enrolled population (in years) 22.6
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Substance used Opioid
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Interventions studied? Combined behavioral and 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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Substance-related problems or symptoms scale
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Age variation of enrolled population (in years) 1.9
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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 Upper income
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Results & Comparisons


Results Data
Outcome: pct abstinent for opioid      Population: All Participants
Time Point Measure Buprenorphine-Naloxone_Memantine15_CBT Buprenorphine-Naloxone_Memantine30_CBT Buprenorphine-Naloxone_Placebo_CBT


0 months

N Analyzed
Counts


2 months

N Analyzed 24 27 29
Counts 3 11 10


3 months

N Analyzed 3 11 10
Counts 1 9 3
Outcome: Adverse event      Population: All Participants
Time Point Measure Buprenorphine-Naloxone_Memantine15_CBT Buprenorphine-Naloxone_Memantine30_CBT Buprenorphine-Naloxone_Placebo_CBT


3 months

N Analyzed 24 27 29
Counts 0 0 0
Outcome: Adverse event      Population: All Participants
Time Point Measure Buprenorphine-Naloxone_Memantine15_CBT Buprenorphine-Naloxone_Memantine30_CBT Buprenorphine-Naloxone_Placebo_CBT


3 months

N Analyzed 24 27 29
Counts 0 0 0
Outcome: Adverse event      Population: All Participants
Time Point Measure Buprenorphine-Naloxone_Memantine15_CBT Buprenorphine-Naloxone_Memantine30_CBT Buprenorphine-Naloxone_Placebo_CBT


3 months

N Analyzed 24 27 29
Counts 0 0 0
Outcome: Adverse event      Population: All Participants
Time Point Measure Buprenorphine-Naloxone_Memantine15_CBT Buprenorphine-Naloxone_Memantine30_CBT Buprenorphine-Naloxone_Placebo_CBT


3 months

N Analyzed 24 27 29
Counts 30 39 49
Outcome: Adverse event      Population: All Participants
Time Point Measure Buprenorphine-Naloxone_Memantine15_CBT Buprenorphine-Naloxone_Memantine30_CBT Buprenorphine-Naloxone_Placebo_CBT


3 months

N Analyzed 24 27 29
Percentage 1.7 1.7 4.2
Outcome: Adverse event      Population: All Participants
Time Point Measure Buprenorphine-Naloxone_Memantine15_CBT Buprenorphine-Naloxone_Memantine30_CBT Buprenorphine-Naloxone_Placebo_CBT


3 months

N Analyzed 24 27 29
Percentage nr 4.2 3.2
Outcome: Adverse event      Population: All Participants
Time Point Measure Buprenorphine-Naloxone_Memantine15_CBT Buprenorphine-Naloxone_Memantine30_CBT Buprenorphine-Naloxone_Placebo_CBT


3 months

N Analyzed 24 27 29
Percentage nr 3.3 0.8
Outcome: Adverse event      Population: All Participants
Time Point Measure Buprenorphine-Naloxone_Memantine15_CBT Buprenorphine-Naloxone_Memantine30_CBT Buprenorphine-Naloxone_Placebo_CBT


3 months

N Analyzed 24 27 29
Percentage nr 2.5 2.5
Outcome: Adverse event      Population: All Participants
Time Point Measure Buprenorphine-Naloxone_Memantine15_CBT Buprenorphine-Naloxone_Memantine30_CBT Buprenorphine-Naloxone_Placebo_CBT


3 months

N Analyzed 24 27 29
Percentage 1.6 1.6 1.6
Outcome: Adverse event      Population: All Participants
Time Point Measure Buprenorphine-Naloxone_Memantine15_CBT Buprenorphine-Naloxone_Memantine30_CBT Buprenorphine-Naloxone_Placebo_CBT


3 months

N Analyzed 24 27 29
Percentage 4.2 4.2 12.7
Outcome: Adverse event      Population: All Participants
Time Point Measure Buprenorphine-Naloxone_Memantine15_CBT Buprenorphine-Naloxone_Memantine30_CBT Buprenorphine-Naloxone_Placebo_CBT


3 months

N Analyzed 24 27 29
Percentage 2.5 nr 1.7
Outcome: opioid      Population: 122240
Time Point Measure Buprenorphine-Naloxone_Memantine15_CBT Buprenorphine-Naloxone_Memantine30_CBT Buprenorphine-Naloxone_Placebo_CBT


0 months

N Analyzed 27 28 32
Mean 0.71 0.75 0.73
SD
SE 0.06 0.04 0.04


3 months

N Analyzed 24 27 29
Mean 0.27 0.00 0.39
SD
SE 0.10 0.0 0.14


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 Adjusted
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Co-interventions (performance bias): Performance bias because co-interventions were different across groups Yes
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Compliance (performance bias): Performance bias due to inappropriate compliance with interventions across groups Yes 82%, no difference 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
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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 Urn randomization
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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
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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
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Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data High 76% loss
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Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting
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Quality Rating
Guideline Used Overall Rating