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OpenTrials
Completed

NCT Number: NCT03254043

Evaluating a Novel Medication Device for Methadone Dosing

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.

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Key information

Conditions

Opioid-use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Addiction Treatment Services (ATS)

Baltimore, Maryland, 21224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Take-home Dosing Procedures

Behavioral

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

Primary outcomes

  1. 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

  2. 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)

  3. 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.

  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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 18, 2017
Registry last updated
Sep 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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