Evaluating a Novel Medication Device for Methadone Dosing
NCT ID: NCT03254043
Last Updated: 2020-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
26 participants
INTERVENTIONAL
2018-01-31
2020-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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Treatment-as-Usual
Participants will routine methadone clinic care.
Take-home Dosing Procedures
Within-subject evaluation across 2 phases with a final choice condition
Take-home Dosing using MedMinder "Jon" Electronic Pill Box
Participants will receive 50% of their methadone dose in the morning in the clinic and 50% of their dose will be dispensed in an electronic pill box for participants to take at home later that day.
Take-home Dosing Procedures
Within-subject evaluation across 2 phases with a final choice condition
Choice Phase
Participants will be allowed to select one final Treatment-As-Usual or the MedMinder "Jon" Electronic Pill Box for the final phase of the study.
Take-home Dosing Procedures
Within-subject evaluation across 2 phases with a final choice condition
Interventions
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Take-home Dosing Procedures
Within-subject evaluation across 2 phases with a final choice condition
Eligibility Criteria
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Inclusion Criteria
* Receiving methadone for the treatment of opioid use disorder for at least 90 days and having been on the same methadone dose for at least 30 days
* Have previously received a take-home dose of methadone as part of routine care
* Be willing to comply with the study schedule
* Be a methadone patient in the clinic within which this study is being conducted
Exclusion Criteria
* Presence of an acute medical problems that requires immediate or intense medical management
* Presence of serious or unstable mental illness that interferes with study procedures
* Planning to leave methadone treatment within the next 12 weeks
* Being maintained on a dose of methadone that is less than 10mg or more than 100mg
* Currently receiving split doses of methadone as part of routine care
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Kelly Dunn, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Addiction Treatment Services (ATS)
Baltimore, Maryland, United States
Countries
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Other Identifiers
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IRB00145200
Identifier Type: -
Identifier Source: org_study_id
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