Evaluating a Novel Medication Device for Methadone Dosing

Johns Hopkins University

Status: Completed

Conditions: Opioid-use Disorder

Treatments: Behavioral: Take-home Dosing Procedures

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03254043

R34DA042926-01A1 (U.S. NIH Grant/Contract)

IRB00145200

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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26 participants in 3 patient groups

Treatment-as-Usual

Active Comparator group

Description:

Participants will routine methadone clinic care.

Treatment:

Behavioral: Take-home Dosing Procedures

Take-home Dosing using MedMinder "Jon" Electronic Pill Box

Experimental group

Description:

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.

Treatment:

Behavioral: Take-home Dosing Procedures

Choice Phase

Other group

Description:

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.

Treatment:

Behavioral: Take-home Dosing Procedures