Evaluating a Novel Medication Device for Methadone Dosing

NCT03254043 | Completed

• 2 other identifiers: IRB00145200R34DA042926-01A1
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid-use Disorder

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (3)

Treatment-as-Usual

ACTIVE COMPARATOR

Participants will routine methadone clinic care.

Behavioral: Take-home Dosing Procedures

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

EXPERIMENTAL

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

Choice Phase

OTHER

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

Interventions

Take-home Dosing Procedures BEHAVIORAL

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

Choice Phase; Take-home Dosing using MedMinder "Jon" Electronic Pill Box; Treatment-as-Usual

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Addiction Treatment Services (ATS)

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Kelly Dunn, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: August 18, 2017
• Study Start: January 31, 2018
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: September 28, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)