Evaluating a Novel Medication Device for Methadone Dosing

Study Overview
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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.

Official Title
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Evaluating a Novel Medication Device for Methadone Dosing

Conditions
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Opioid-use Disorder

Intervention / Treatment
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* Behavioral: Take-home Dosing Procedures


Participation Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment-as-Usual<br>Participants will routine methadone clinic care. | Behavioral: Take-home Dosing Procedures<br>* Within-subject evaluation across 2 phases with a final choice condition<br>|
| Experimental: Take-home Dosing using MedMinder Jon Electronic Pill Box<br>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. | Behavioral: Take-home Dosing Procedures<br>* Within-subject evaluation across 2 phases with a final choice condition<br>|
| Other: Choice Phase<br>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. | Behavioral: Take-home Dosing Procedures<br>* Within-subject evaluation across 2 phases with a final choice condition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant willingness to use the MedMinder Jon electronic pillbox to manage take-home doses of methadone | Feasibility will be assessed by conducting a survival analysis of participant retention in the study | Week 12 | 
| Participant acceptance of the MedMinder Jon electronic pillbox to manage take-home doses of methadone | Percent of participants who select the Electronic Pill Box during their Choice phase (phase 3) | Week 9 | 
| Change in participant satisfaction | 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. | Week 4 | 
| Change in participant satisfaction | 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. | Week 8 |