Opioid-use Disorder
Conditions
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.
Interventions
BEHAVIORALTake-home Dosing Procedures
Within-subject evaluation across 2 phases with a final choice condition
Sponsors
National Institute on Drug Abuse (NIDA)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
| Change in participant satisfaction | Week 4 | 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. |
Countries
United States
Outcome results
None listed