Evaluating a Novel Medication Device for Methadone Dosing

NCT ID: NCT03254043

Last Updated: 2020-09-28

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-31

Study Completion Date

2020-03-30

Brief Summary

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This study will evaluate whether a commercially available, secure, electronic pill box is a feasible, acceptable, and satisfactory method to manage take-home dosing of methadone for both methadone clinic patients and staff members.

Detailed Description

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Conditions

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Opioid-use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Treatment-as-Usual

Participants will routine methadone clinic care.

Group Type ACTIVE_COMPARATOR

Take-home Dosing Procedures

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

Take-home Dosing Procedures

Intervention Type BEHAVIORAL

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.

Group Type OTHER

Take-home Dosing Procedures

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 18 years or older
* 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

* Pregnancy
* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Other Identifiers

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R34DA042926-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00145200

Identifier Type: -

Identifier Source: org_study_id

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