Opioid-use DisorderNCT03254043
Evaluating a Novel Medication Device for Methadone Dosing
A study testing Take-home Dosing Procedures in people with Opioid-use Disorder, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- Take-home Dosing Procedures
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2018to 30 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Addiction Treatment Services (ATS)
Baltimore, Maryland, 21224
About this study
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
- Being tested
- Take-home Dosing Procedures
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Take-home Dosing ProceduresBehavioural
Within-subject evaluation across 2 phases with a final choice condition
| Study group | Role | What they receive |
|---|---|---|
| Treatment-as-Usual | Active comparator | Participants will routine methadone clinic care. Receives: 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. Receives: 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. Receives: Behavioral: Take-home Dosing Procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start31 Jan 2018
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Kelly Dunn, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254043
- Sponsor's protocol ID
- IRB00145200
- Other IDs
- R34DA042926-01A1
- Status last verified
- Sep 2020
- First submitted
- 9 Aug 2017
- Last updated
- 28 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Novel Medication Device for Methadone Dosing
- ClinicalTrials.gov ID
- NCT03254043
- Acronym / sponsor ID
- IRB00145200
- Conditions
- Opioid-use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 18 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment-as-Usual | Active comparator | Behavioral: Take-home Dosing ProceduresParticipants will routine methadone clinic care. |
| Take-home Dosing using MedMinder "Jon" Electronic Pill Box | Experimental | Behavioral: Take-home Dosing ProceduresParticipants 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. |
| Choice Phase | Other | Behavioral: Take-home Dosing ProceduresParticipants will be allowed to select one final Treatment-As-Usual or the MedMinder "Jon" Electronic Pill Box for the final phase of the study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Take-home Dosing ProceduresWithin-subject evaluation across 2 phases with a final choice condition | Behavioural | Choice Phase, Take-home Dosing using MedMinder "Jon" Electronic Pill Box, Treatment-as-Usual |
Primary outcome
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
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)
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly Dunn, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Take-home Dosing Procedures in people with Opioid-use Disorder, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant willingness to use the MedMinder "Jon" electronic pillbox to manage take-home doses of methadone (time frame: Week 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2020.