Evaluating a Novel Medication Device for Methadone Dosing

Opioid-use Disorder Clinical Trial

Official title:

Evaluating a Novel Medication Device for Methadone Dosing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03254043
• Other study ID #: IRB00145200
• Secondary ID: R34DA042926-01A1
• Status: Completed
• Phase: N/A
• Start date: January 31, 2018
• Est. completion date: March 30, 2020

Study information

• Verified date: September 2020
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid-use Disorder

Intervention

Behavioral:
• Take-home Dosing Procedures
Within-subject evaluation across 2 phases with a final choice condition

Locations

Country	Name	City	State
United States	Addiction Treatment Services (ATS)	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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