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Evaluating a Novel Medication Device for Methadone Dosing

Primary Purpose

Opioid-use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Take-home Dosing Procedures
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Opioid-use Disorder

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Addiction Treatment Services (ATS)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Other

Arm Label

Treatment-as-Usual

Take-home Dosing using MedMinder "Jon" Electronic Pill Box

Choice Phase

Arm Description

Participants will routine methadone clinic care.

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.

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.

Outcomes

Primary Outcome Measures

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
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)
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 9, 2017
Last Updated
September 24, 2020
Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03254043
Brief Title
Evaluating a Novel Medication Device for Methadone Dosing
Official Title
Evaluating a Novel Medication Device for Methadone Dosing
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 31, 2018 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
March 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment-as-Usual
Arm Type
Active Comparator
Arm Description
Participants will routine methadone clinic care.
Arm Title
Take-home Dosing using MedMinder "Jon" Electronic Pill Box
Arm Type
Experimental
Arm Description
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.
Arm Title
Choice Phase
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Take-home Dosing Procedures
Intervention Description
Within-subject evaluation across 2 phases with a final choice condition
Primary Outcome Measure Information:
Title
Participant willingness to use the MedMinder "Jon" electronic pillbox to manage take-home doses of methadone
Description
Feasibility will be assessed by conducting a survival analysis of participant retention in the study
Time Frame
Week 12
Title
Participant acceptance of the MedMinder "Jon" electronic pillbox to manage take-home doses of methadone
Description
Percent of participants who select the Electronic Pill Box during their Choice phase (phase 3)
Time Frame
Week 9
Title
Change in participant satisfaction
Description
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
Title
Change in participant satisfaction
Description
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly Dunn, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Addiction Treatment Services (ATS)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluating a Novel Medication Device for Methadone Dosing

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