Opioid-use DisorderNCT03586466
Improving Office Based Treatment of Opioid Use Disorder With Technology
A study testing BupreCare, Buprenorphine/naloxone and MEMS in people with Opioid-use Disorder, run by MedicaSafe, Inc. at 2 sites in United States.
Trial summary
The goal of this study is to evaluate whether using a novel drug-device combination to deliver buprenorphine/naloxone (B/N) to patients in office-based treatment for Opioid Use Disorder (OUD) is an effective way to improve compliance and treatment outcomes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- BupreCare, Buprenorphine/naloxone and MEMS
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2018to Sep 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be between the ages of 18 and 65 years old
- Be able to provide informed consent
- Be English-speaking
- Have consistent phone and/or internet access
- Deemed by physician as medically, psychiatrically, and otherwise appropriate for buprenorphine therapy
- Maintained on a stable B/N dose
Who cannot join
- Be younger than 18 or older than 65 years of age
- Chronic pain
- Be non-English speaking
- Be unable to complete informed consent
- Be pregnant
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 1 recruiting
- Recruiting
Friends Research Institute
Baltimore, Maryland, 21201
Kathy Couvillion, BA, 410-837-3977 ext. 242, kcouvillion@friendsresearch.org
Michael Gordon, DPA
- Terminated
Artemis Institute for Clinical Research
San Diego, California, 92103
About this study
Official title: Pilot for Improved Office Based Treatment of Opioid-Dependence
The goal of this study is to evaluate whether using a novel drug-device combination to deliver buprenorphine/naloxone (B/N) to patients in office-based treatment for Opioid Use Disorder (OUD) is an effective way to improve compliance and treatment outcomes. The system introduces psychological and behavioral supports in addition to securing the medication between doses.
Read the detailed description
The misuse and abuse of opioids is a serious public health problem. SAMHSA estimates that more than 12 million Americans misuse prescription opioids for nonmedical purposes annually. The costs of this problem are substantial, both to individuals and society: total costs of prescription opioid misuse, abuse, and overdose to the US is estimated at $78.5 billion annually. Additionally, the prevalence of opioid abuse and associated costs are on the rise. In spite of this, the availability and acceptance of treatment with medications has not kept pace with the spread of the epidemic.
Prescription of buprenorphine/naloxone (B/N) is intended to address a behavioral health issue (misuse of opioids) as a component of Medication Assisted Treatment (MAT) for those who are pharmacologically dependent on opioids. In chronic illness, patient compliance and adherence with a prescribed regimen has been shown to correlate with treatment success, and conversely poor patient compliance, commonly documented, correlates with poor outcomes. Studies have demonstrated that with B/N specifically, compliance is predictive of both relapse and treatment retention. Relapse events are costly in terms of total healthcare expenditures (around $15,000 per patient), and personally - upwards of 800,000 years of potential life lost before the age of 65 in the US alone.
This study seeks to examine the effectiveness of MedicaSafe's BupreCare system in the delivery of MAT to those with OUD. The BupreCare system is a connected, locking, oral medication dispenser and secure pill cartridges coupled with an online platform. The system is programmed with a treatment plan to allow for the dispensation of medications in the right dose at the right time. Dispensation is recorded and collated in treatment reports to track patient adherence to their regimen. The project intends to ameliorate issues associated with MAT by curbing the negative effects of medication nonadherence and diversion, while simultaneously increasing provider awareness of patient behaviors and needs.
Patients aged 18-65 (inclusive) will be enrolled at Friends Research Institute in a field trial. Patients will be maintained on a stable dose of B/N, and randomized into one of three arms (BupreCare, TAU, or TAU with MEMS tracking). Subjects will have bi-weekly study visits over the course of 12 weeks. Assessments will be collected at baseline, and then every 2 weeks following study initiation.
- Conditions
- Opioid-use Disorder
- Being tested
- BupreCare, Buprenorphine/naloxone, MEMS
- Keywords
- opioid abuse, opioid dependence, medication assisted treatment, opioids, buprenorphine, buprenorphine/naloxone, MedicaSafe
- 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.
BupreCareDevice
Also called MedicaSafe device
Subjects will receive their medication in a MedicaSafe device. Medication will be dispensed in accordance with the programmed treatment plan for each subject. Subjects will complete a "Check-In" remotely each week with their device.
Buprenorphine/naloxoneDrug
Subjects will be given buprenorphine/naloxone as a component of Medication Assisted Treatment (MAT).
MEMSOther
Subjects will receive their medication in a MEMS pill bottle.
| Study group | Role | What they receive |
|---|---|---|
| BupreCare | Experimental | The BupreCare system is an integrated medication management and patient monitoring system, consisting of a smart medication-tracking dispenser and online platform. The dispensing component is a portable smart dispenser and secure pill cartridges that is programmed with an individualized treatment plan for each patient. This arm will be assigned a MedicaSafe device that will have their buprenorphine/naloxone securely stored. Treatment reports of their dispensation history will be collated and available to the treatment team. Receives: Device: BupreCare; Drug: Buprenorphine/naloxone |
| Treatment as Usual | Active comparator | This arm represents an active comparator for the experimental group. Subjects in this group will undergo TAU, with no changes to the way that they receive their medication. They will have pill counts bi-weekly to examine adherence. Receives: Drug: Buprenorphine/naloxone |
| Treatment as Usual with MEMS | Active comparator | This arm represents a second active comparator for the experimental group. Subjects in this group will receive their medication in a MEMS pill bottle, but otherwise will undergo TAU. Receives: Drug: Buprenorphine/naloxone; Other: MEMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance
Determined by the number of days medication was taken appropriately compared to total days study medication should have been taken. For BupreCare, this will be done using the treatment reports from the device. For MEMS, this will be done with the data from the MEMS device. For TAU, this will be done with pill counts. Pill counts and dispensation reports will be supplemented by the Timeline Follow-back Assessment.
Measured: Compliance checks will be done every 14 days. Total compliance for each subject will be looked at across the 12-week period of participation.
Secondary outcomes (2)
Urine Drug Screens
Urine Drug Tests will be given at each in-person study visit to test for opiates and other illicit substances. The proportion of negative urine samples (for opiates) will serve as a secondary endpoint.
Measured: Bi-weekly, across the 12-week participation period.
Relapse
This will be determined by opiate-positive Urine Drug Screens.
Measured: Examined bi-weekly across the 12-week participation period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start1 Dec 2018
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MedicaSafe, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Friends Research Institute, Inc.
- Responsible party
- Sponsor
- Investigators
- Anand Mattai, MD, Principal investigator, MedicaSafe, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03586466
- Sponsor's protocol ID
- Pro00023570
- Status last verified
- Jul 2019
- First submitted
- 2 Jul 2018
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot for Improved Office Based Treatment of Opioid-Dependence
- ClinicalTrials.gov ID
- NCT03586466
- Acronym / sponsor ID
- Pro00023570
- Conditions
- Opioid-use Disorder
- Keywords
- opioid abuse, opioid dependence, medication assisted treatment, opioids, buprenorphine, buprenorphine/naloxone, MedicaSafe
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- MedicaSafe, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Friends Research Institute, Inc.
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 13 Jul 2018 (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.
The goal of this study is to evaluate whether using a novel drug-device combination to deliver buprenorphine/naloxone (B/N) to patients in office-based treatment for Opioid Use Disorder (OUD) is an effective way to improve compliance and treatment outcomes. The system introduces psychological and behavioral supports in addition to securing the medication between doses.
Detailed description
The misuse and abuse of opioids is a serious public health problem. SAMHSA estimates that more than 12 million Americans misuse prescription opioids for nonmedical purposes annually. The costs of this problem are substantial, both to individuals and society: total costs of prescription opioid misuse, abuse, and overdose to the US is estimated at $78.5 billion annually. Additionally, the prevalence of opioid abuse and associated costs are on the rise. In spite of this, the availability and acceptance of treatment with medications has not kept pace with the spread of the epidemic.
Prescription of buprenorphine/naloxone (B/N) is intended to address a behavioral health issue (misuse of opioids) as a component of Medication Assisted Treatment (MAT) for those who are pharmacologically dependent on opioids. In chronic illness, patient compliance and adherence with a prescribed regimen has been shown to correlate with treatment success, and conversely poor patient compliance, commonly documented, correlates with poor outcomes. Studies have demonstrated that with B/N specifically, compliance is predictive of both relapse and treatment retention. Relapse events are costly in terms of total healthcare expenditures (around $15,000 per patient), and personally - upwards of 800,000 years of potential life lost before the age of 65 in the US alone.
This study seeks to examine the effectiveness of MedicaSafe's BupreCare system in the delivery of MAT to those with OUD. The BupreCare system is a connected, locking, oral medication dispenser and secure pill cartridges coupled with an online platform. The system is programmed with a treatment plan to allow for the dispensation of medications in the right dose at the right time. Dispensation is recorded and collated in treatment reports to track patient adherence to their regimen. The project intends to ameliorate issues associated with MAT by curbing the negative effects of medication nonadherence and diversion, while simultaneously increasing provider awareness of patient behaviors and needs.
Patients aged 18-65 (inclusive) will be enrolled at Friends Research Institute in a field trial. Patients will be maintained on a stable dose of B/N, and randomized into one of three arms (BupreCare, TAU, or TAU with MEMS tracking). Subjects will have bi-weekly study visits over the course of 12 weeks. Assessments will be collected at baseline, and then every 2 weeks following study initiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BupreCare | Experimental | Device: BupreCare, Drug: Buprenorphine/naloxoneThe BupreCare system is an integrated medication management and patient monitoring system, consisting of a smart medication-tracking dispenser and online platform. The dispensing component is a portable smart dispenser and secure pill cartridges that is programmed with an individualized treatment plan for each patient. This arm will be assigned a MedicaSafe device that will have their buprenorphine/naloxone securely stored. Treatment reports of their dispensation history will be collated and available to the treatment team. |
| Treatment as Usual | Active comparator | Drug: Buprenorphine/naloxoneThis arm represents an active comparator for the experimental group. Subjects in this group will undergo TAU, with no changes to the way that they receive their medication. They will have pill counts bi-weekly to examine adherence. |
| Treatment as Usual with MEMS | Active comparator | Drug: Buprenorphine/naloxone, Other: MEMSThis arm represents a second active comparator for the experimental group. Subjects in this group will receive their medication in a MEMS pill bottle, but otherwise will undergo TAU. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be between the ages of 18 and 65 years old
- Be able to provide informed consent
- Be English-speaking
- Have consistent phone and/or internet access
- Deemed by physician as medically, psychiatrically, and otherwise appropriate for buprenorphine therapy
Key exclusion criteria (5 listed)
- Be younger than 18 or older than 65 years of age
- Chronic pain
- Be non-English speaking
- Be unable to complete informed consent
- Be pregnant
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 |
|---|---|---|
| BupreCareAlso: MedicaSafe deviceSubjects will receive their medication in a MedicaSafe device. Medication will be dispensed in accordance with the programmed treatment plan for each subject. Subjects will complete a "Check-In" remotely each week with their device. | Device | BupreCare |
| Buprenorphine/naloxoneSubjects will be given buprenorphine/naloxone as a component of Medication Assisted Treatment (MAT). | Drug | BupreCare, Treatment as Usual, Treatment as Usual with MEMS |
| MEMSSubjects will receive their medication in a MEMS pill bottle. | Other | Treatment as Usual with MEMS |
Primary outcome
Compliance
Time frame: Compliance checks will be done every 14 days. Total compliance for each subject will be looked at across the 12-week period of participation.
Determined by the number of days medication was taken appropriately compared to total days study medication should have been taken. For BupreCare, this will be done using the treatment reports from the device. For MEMS, this will be done with the data from the MEMS device. For TAU, this will be done with pill counts. Pill counts and dispensation reports will be supplemented by the Timeline Follow-back Assessment.
2 secondary outcomes
Urine Drug Screens
Time frame: Bi-weekly, across the 12-week participation period.
Relapse
Time frame: Examined bi-weekly across the 12-week participation period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
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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.
Anand Mattai, MD principal investigator
MedicaSafe, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BupreCare, Buprenorphine/naloxone and MEMS in people with Opioid-use Disorder, run by MedicaSafe, Inc. at 2 sites 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caitlin Kelliher (6466611092, caitlin.kelliher@medicasafe.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance (time frame: Compliance checks will be done every 14 days. Total compliance for each subject will be looked at across the 12-week period of participation.). 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 19 Jul 2019.