Opioid-use DisorderPhase 2/3MATPharmNCT04139213
Medication Maintenance Therapy in Community Pharmacy Settings
A Phase 2/3 study testing buprenorphine/naloxone oral product, injectable naltrexone and Pharmacy maintenance addiction care in people with Opioid-use Disorder, run by Lifespan at 1 site in United States.
Trial summary
The goal of this study is to compare pharmacy-based medication assisted treatment (MAT) with usual care MAT for people with opioid use disorder. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- buprenorphine/naloxone oral product, injectable naltrexone and Pharmacy maintenance addiction care
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2019to 1 Oct 2022
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- English speaking
- Currently enrolled at a MAT site for the treatment of OUD, maintained on a stable MAT (BNX, NTX) dose for at least 2 days or interested in induction
- Able and willing to provide written informed consent and secondary contact
Who cannot join
- currently pregnant or trying to get pregnant;
- plans to move or leave the state during the study, including pending legal action;
- self reported past year suicide attempt or self-reported past year suicidal thoughts with a plan;
- Patient is currently being treated for an acute illness or has a condition that is not stable including but not limited to an upcoming surgical procedure, hospitalization, or complex treatment regimen (e.g., chemotherapy, HCV treatment, has surgery scheduled, has procedures anticipated, has anticipated dose changes with other medication), that is likely to require ongoing, intense clinical management
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Official title: Comparing Medication Maintenance in Comprehensive Community and Pharmacy Settings to Enhance Engagement
The goal of this study is to compare pharmacy-based medication assisted treatment (MAT) with usual care MAT for people with opioid use disorder.
Read the detailed description
This study compares pharmacy-based medication assisted treatment (MAT) with usual care MAT. This will be the first study to use a randomized controlled trial design to test the multisite implementation of known effective interventions to treat opioid use disorder and prevent fatal opioid overdose (treatment with buprenorphine and natlrexone) in a community pharmacy setting. Understanding how this model can improve engagement in care within innovative systems of MAT delivery like the Rhode Island Centers of Excellence in MAT model as well as the more traditional office based opioid therapy (OBOT) arrangement, and for patients with shorter and longer time on stabilized MAT doses advances the science of addiction health services.
This study presents an opportunity to compare clinical outcomes of patients randomized to receive the same medications but in different settings that are equipped with differing levels of counseling expectations and access to wrap-around services. In this way, the trial helps to inform whether-and for whom--the limited support services in the pharmacy are sufficient to engage and retain patients in MAT, or if ready access to comprehensive services are necessary. Approximately 86% of Americans live within 5 miles of a pharmacy, making pharmacists the most accessible health care professionals. This model could redefine the role of the pharmacy.
The completed initial phase of the study (Phase 1) involved a pilot of the pharmacy MAT care model. The current phase of the study (Phase 2) is a randomized controlled trial comparing the pharmacy MAT care model to usual MAT care.
The aim of the current phase is to conduct a randomized controlled trial of 250 medication-stabilized (with BNX or NTX) patients with OUD receiving MAT care in Rhode Island, comparing engagement and clinical outcomes for patients followed up in a usual care model to those maintained and followed up in a pharmacy MAT care model.
- Conditions
- Opioid-use Disorder
- Being tested
- buprenorphine/naloxone oral product, injectable naltrexone, Pharmacy maintenance addiction care, oral naltrexone
- 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.
buprenorphine/naloxone oral productDrug
Also called Suboxone
To treat opioid use disorder, buprenorphine/naloxone will be provided by a study pharmacist under a collaborative pharmacy practice agreement on a weekly or monthly basis, unless the care plan specifies greater frequency of pharmacy visit. The median expected dose of buprenorphine/naloxone (sublingual film or tablet) is 8 to 24 mg daily, and may be adjusted per the collaborative pharmacy practice agreement.
injectable naltrexoneDrug
Also called Vivitrol
To treat opioid use disorder, injectable naltrexone will be provided by a study pharmacist under a collaborative pharmacy practice agreement on a monthly (injectable naltrexone) basis. The expected dose of injectable naltrexone will be approximately 380 mg. Injectable naltrexone will be dispensed and prepared by the pharmacist but administered by nursing staff for the pilot study.
Pharmacy maintenance addiction careOther
Patients randomized to the pharmacy study arm and on a stable dose of buprenorphine/naloxone or naltrexone will receive maintenance care at the pharmacy for up to three months. Patients will visit for check-ins with a pharmacist on a monthly, weekly, or more frequent basis, depending on the individual treatment plan. Patients on buprenorphine/naloxone will be dispensed their medication at study visits, whereas patients taking injectable naltrexone will be dispensed it monthly by the pharmacist. All patients will visit the pharmacy at least monthly for addiction care (assessment, toxicological testing).
oral naltrexoneDrug
To augment care for patients receiving injectable naltrexone for the treatment of OUD and treat cravings that may arise before their scheduled injection, patients prescribed injectable naltrexone may be provided a several day supply of oral naltrexone by a study pharmacist under a collaborative pharmacy practice agreement. The expected dose of oral naltrexone will be approximately 25-50 mg daily.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | usual medication assisted treatment for maintenance care of opioid use disorder Receives: Drug: buprenorphine/naloxone oral product; Drug: injectable naltrexone; Drug: oral naltrexone |
| Pharmacy MAT | Experimental | pharmacy-based medication assisted treatment for maintenance care of opioid use disorder Receives: Drug: buprenorphine/naloxone oral product; Drug: injectable naltrexone; Other: Pharmacy maintenance addiction care; Drug: oral naltrexone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention in MAT
Proportion of patients attending one or more visits with MAT providers every 30 days for up to 90 days post randomization according to the medical or pharmacy record
Measured: up to 90 days post randomization
Relapse to drug use
Proportion of patients who relapse to drug use, defined as absence of the MAT medication and presence of heroin or other illicit opioids. Measured by toxicological (urine or oral) analysis, with samples collected at every visit (i.e., <every 30 days), or at the 3-month interview at the research site. For patients attending visits, the toxicological results will consider those in the medical or pharmacy record. Urine or oral samples will test for drugs of abuse plus fentanyl, using a rapid qualitative immunoassay.
Measured: up to 90 days post randomization
Secondary outcomes (3)
Primary care visits
Measured by patient self-report, patient medical record review, or by direct contact with the facility, clinician, or both.
The self report item asks: How many times did you visit your primary care provider (do NOT count visits to providers at the emergency department) in the past 90 DAYS (since starting this study)?
- Never, no provider
- Never, but I have a provider
- Once or twice
- 3-5 times
- 6 or more times
Measured: up to 90 days post randomization
Emergency department visits
Measured by patient self-report, patient medical record review, or by direct contact with the facility, clinician, or both.
The self report item asks: How often did you visit the emergency room in the past 90 DAYS (since starting this study)?
- Never
- Once or twice
- 3-5 times
- 6 or more times
Measured: up to 90 days post randomization
Hospitalizations
Measured as by patient self-report, patient medical record review, or by direct contact with the facility, clinician, or both.
The self report item asks: How often were you hospitalized in the past 90 DAYS (since starting this study)?
- Never
- Once or twice
- 3-5 times
- 6 or more times
Measured: up to 90 days post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start25 Jul 2019
- Primary completion30 Sep 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lifespan
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rhode Island, The Miriam Hospital
- Responsible party
- Principal investigator, Traci Green, Lifespan
- Investigators
- Traci C Green, PhD, MSc, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04139213
- Sponsor's protocol ID
- 9919
- Acronym
- MATPharm
- Status last verified
- Aug 2022
- First submitted
- 23 Oct 2019
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol and informed consent form will be shared.
Publications
Green TC, Serafinski R, Clark SA, Rich JD, Bratberg J. Physician-Delegated Unobserved Induction with Buprenorphine in Pharmacies. N Engl J Med. 2023 Jan 12;388(2):185-186. doi: 10.1056/NEJMc2208055. No abstract available.
PubMed 36630629
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Medication Maintenance in Comprehensive Community and Pharmacy Settings to Enhance Engagement
- ClinicalTrials.gov ID
- NCT04139213
- Acronym / sponsor ID
- MATPharm / 9919
- Conditions
- Opioid-use Disorder
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- LifespanUniversity, hospital or other
- Collaborators
- University of Rhode Island, The Miriam Hospital
- Study start
- 25 Jul 2019 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 25 Oct 2019 (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 compare pharmacy-based medication assisted treatment (MAT) with usual care MAT for people with opioid use disorder.
Detailed description
This study compares pharmacy-based medication assisted treatment (MAT) with usual care MAT. This will be the first study to use a randomized controlled trial design to test the multisite implementation of known effective interventions to treat opioid use disorder and prevent fatal opioid overdose (treatment with buprenorphine and natlrexone) in a community pharmacy setting. Understanding how this model can improve engagement in care within innovative systems of MAT delivery like the Rhode Island Centers of Excellence in MAT model as well as the more traditional office based opioid therapy (OBOT) arrangement, and for patients with shorter and longer time on stabilized MAT doses advances the science of addiction health services.
This study presents an opportunity to compare clinical outcomes of patients randomized to receive the same medications but in different settings that are equipped with differing levels of counseling expectations and access to wrap-around services. In this way, the trial helps to inform whether-and for whom--the limited support services in the pharmacy are sufficient to engage and retain patients in MAT, or if ready access to comprehensive services are necessary. Approximately 86% of Americans live within 5 miles of a pharmacy, making pharmacists the most accessible health care professionals. This model could redefine the role of the pharmacy.
The completed initial phase of the study (Phase 1) involved a pilot of the pharmacy MAT care model. The current phase of the study (Phase 2) is a randomized controlled trial comparing the pharmacy MAT care model to usual MAT care.
The aim of the current phase is to conduct a randomized controlled trial of 250 medication-stabilized (with BNX or NTX) patients with OUD receiving MAT care in Rhode Island, comparing engagement and clinical outcomes for patients followed up in a usual care model to those maintained and followed up in a pharmacy MAT care model.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Drug: buprenorphine/naloxone oral product, Drug: injectable naltrexone, Drug: oral naltrexoneusual medication assisted treatment for maintenance care of opioid use disorder |
| Pharmacy MAT | Experimental | Drug: buprenorphine/naloxone oral product, Drug: injectable naltrexone, Other: Pharmacy maintenance addiction care, Drug: oral naltrexonepharmacy-based medication assisted treatment for maintenance care of opioid use disorder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- English speaking
- Currently enrolled at a MAT site for the treatment of OUD, maintained on a stable MAT (BNX, NTX) dose for at least 2 days or interested in induction
- Able and willing to provide written informed consent and secondary contact
Key exclusion criteria (4 listed)
- currently pregnant or trying to get pregnant;
- plans to move or leave the state during the study, including pending legal action;
- self reported past year suicide attempt or self-reported past year suicidal thoughts with a plan;
- Patient is currently being treated for an acute illness or has a condition that is not stable including but not limited to an upcoming surgical procedure, hospitalization, or complex treatment regimen (e.g., chemotherapy, HCV treatment, has surgery scheduled, has procedures anticipated, has anticipated dose changes with other medication), that is likely to require ongoing, intense clinical management
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 |
|---|---|---|
| buprenorphine/naloxone oral productAlso: SuboxoneTo treat opioid use disorder, buprenorphine/naloxone will be provided by a study pharmacist under a collaborative pharmacy practice agreement on a weekly or monthly basis, unless the care plan specifies greater frequency of pharmacy visit. The median expected dose of buprenorphine/naloxone (sublingual film or tablet) is 8 to 24 mg daily, and may be adjusted per the collaborative pharmacy practice agreement. | Drug | Pharmacy MAT, Usual care |
| injectable naltrexoneAlso: VivitrolTo treat opioid use disorder, injectable naltrexone will be provided by a study pharmacist under a collaborative pharmacy practice agreement on a monthly (injectable naltrexone) basis. The expected dose of injectable naltrexone will be approximately 380 mg. Injectable naltrexone will be dispensed and prepared by the pharmacist but administered by nursing staff for the pilot study. | Drug | Pharmacy MAT, Usual care |
| Pharmacy maintenance addiction carePatients randomized to the pharmacy study arm and on a stable dose of buprenorphine/naloxone or naltrexone will receive maintenance care at the pharmacy for up to three months. Patients will visit for check-ins with a pharmacist on a monthly, weekly, or more frequent basis, depending on the individual treatment plan. Patients on buprenorphine/naloxone will be dispensed their medication at study visits, whereas patients taking injectable naltrexone will be dispensed it monthly by the pharmacist. All patients will visit the pharmacy at least monthly for addiction care (assessment, toxicological testing). | Other | Pharmacy MAT |
| oral naltrexoneTo augment care for patients receiving injectable naltrexone for the treatment of OUD and treat cravings that may arise before their scheduled injection, patients prescribed injectable naltrexone may be provided a several day supply of oral naltrexone by a study pharmacist under a collaborative pharmacy practice agreement. The expected dose of oral naltrexone will be approximately 25-50 mg daily. | Drug | Pharmacy MAT, Usual care |
Primary outcome
Retention in MAT
Time frame: up to 90 days post randomization
Proportion of patients attending one or more visits with MAT providers every 30 days for up to 90 days post randomization according to the medical or pharmacy record
Relapse to drug use
Time frame: up to 90 days post randomization
Proportion of patients who relapse to drug use, defined as absence of the MAT medication and presence of heroin or other illicit opioids. Measured by toxicological (urine or oral) analysis, with samples collected at every visit (i.e., <every 30 days), or at the 3-month interview at the research site. For patients attending visits, the toxicological results will consider those in the medical or pharmacy record. Urine or oral samples will test for drugs of abuse plus fentanyl, using a rapid qualitative immunoassay.
3 secondary outcomes
Primary care visits
Time frame: up to 90 days post randomization
Emergency department visits
Time frame: up to 90 days post randomization
Hospitalizations
Time frame: up to 90 days post randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Derived from this study: PubMed 36630629Green TC, Serafinski R, Clark SA, Rich JD, Bratberg J. Physician-Delegated Unobserved Induction with Buprenorphine in Pharmacies. N Engl J Med. 2023 Jan 12;388(2):185-186. doi: 10.1056/NEJMc2208055. No abstract available.
- Individual participant dataSharing planned: Yes. The study protocol and informed consent form will be shared.
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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.
Traci C Green, PhD, MSc principal investigator
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing buprenorphine/naloxone oral product, injectable naltrexone and Pharmacy maintenance addiction care in people with Opioid-use Disorder, run by Lifespan 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 4 inclusion and 4 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 24 Aug 2022. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Retention in MAT (time frame: up to 90 days post randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04139213, which also lists 1 linked publication.
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 24 Aug 2022.