NCT03254043 - Evaluating a Novel Medication Device for Methadone Dosing | Crick

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

26

Conditions

Opioid-use Disorder

Interventions

Take-home Dosing ProceduresBEHAVIORAL

Within-subject evaluation across 2 phases with a final choice condition

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Addiction Treatment Services (ATS)

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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

Time frame: 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)

Time frame: 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.

Time frame: 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.

Time frame: Week 8