Evaluating a Novel Medication Device for Methadone Dosing

September 24, 2020 updated by: Johns Hopkins University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Addiction Treatment Services (ATS)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Treatment-as-Usual
Participants will routine methadone clinic care.
Behavioral: Take-home Dosing Procedures
Within-subject evaluation across 2 phases with a final choice condition
EXPERIMENTAL: Take-home Dosing using MedMinder "Jon" Electronic Pill Box
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
Within-subject evaluation across 2 phases with a final choice condition
OTHER: Choice Phase
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
Within-subject evaluation across 2 phases with a final choice condition

What is the study measuring?

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
Time Frame: Week 12
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
Time Frame: Week 9
Percent of participants who select the Electronic Pill Box during their Choice phase (phase 3)
Week 9
Change in participant satisfaction
Time Frame: 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.
Week 4
Change in participant satisfaction
Time Frame: Week 8
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Kelly Dunn, PhD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 31, 2018

Primary Completion (ACTUAL)

March 30, 2020

Study Completion (ACTUAL)

March 30, 2020

Study Registration Dates

First Submitted

August 9, 2017

First Submitted That Met QC Criteria

August 15, 2017

First Posted (ACTUAL)

August 18, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 28, 2020

Last Update Submitted That Met QC Criteria

September 24, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00145200
  • R34DA042926-01A1 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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