Evaluating a Novel Medication Device for Methadone Dosing

Not Applicable

Completed

• Conditions: Opioid-use Disorder
• Interventions: Behavioral: Take-home Dosing Procedures

• Registration Number: NCT03254043
• Lead Sponsor: Johns Hopkins University

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2017-08-09
• Study First Submitted QC: 2017-08-15
• Study First Posted: 2017-08-18
• Study Start: 2018-01-31
• Primary Completion: 2020-03-30
• Study Completion: 2020-03-30
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-24
• Last Update Posted: 2020-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Take-home Dosing using MedMinder "Jon" Electronic Pill Box	Take-home Dosing Procedures	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-as-Usual	Take-home Dosing Procedures	Participants will routine methadone clinic care.
Choice Phase	Take-home Dosing Procedures	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.

Primary Outcome Measures

Name	Time	Method
Participant acceptance of the MedMinder "Jon" electronic pillbox to manage take-home doses of methadone	Week 9	Percent of participants who select the Electronic Pill Box during their Choice phase (phase 3)
Participant willingness to use the MedMinder "Jon" electronic pillbox to manage take-home doses of methadone	Week 12	Feasibility will be assessed by conducting a survival analysis of participant retention in the study
Change in participant satisfaction	Week 8	Participant satisfaction will be assessed using the Client Satisfaction Questionnaire- an 8-item self-report measure on which patients will rate their satisfaction with treatment on a 4-item Likert scale. Values will be summed for a total satisfaction rating (range 8-32), with higher scores indicating greater satisfaction. Participants will complete the CSQ at week 4 and week 8, and the CSQ ratings from the treatment-as-usual will be subtracted from the ratings following the MedMinder "Jon" electronic pillbox phase as a measure of change in participant satisfaction.

Trial Locations

Locations (1)

Addiction Treatment Services (ATS); 🇺🇸 Baltimore, Maryland, United States