Opioid-use DisorderEarly Phase 1MATPharmNCT03766893
Medication Maintenance Therapy in Community Pharmacy Settings
A Early Phase 1 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 examine how the pharmacy can better optimize treatment expansion by providing pharmacy-based medication assisted treatment (MAT) for maintenance under a collaborative pharmacy practice agreement. 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
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 31 Dec 2018
- Phase
- Early Phase 1
- 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 CODAC site in Rhode Island for the treatment of opioid use disorder;
- maintained on a stable dose of buprenorphine or injectable naltrexone for at least 2 days;
- no stable co-morbid illnesses likely to progress clinically during the pilot study;
- able and willing to provide written informed consent and locator information (working telephone and >2 contacts) to participate.
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;
- any condition that, in the researchers' judgment, interferes with safe study participation or adherence to study procedures, including but not limited to a mental, medical or other substance use disorder that is likely to require ongoing, intense clinical management during the pilot study.
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 examine how the pharmacy can better optimize treatment expansion by providing pharmacy-based medication assisted treatment (MAT) for maintenance under a collaborative pharmacy practice agreement.
Read the detailed description
This study will be the first to develop and use a collaborative pharmacy practice agreement (CPA) for medication assisted treatment (MAT) intended for statewide application. This will also 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 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 initial phase of the study (Phase 1) involves preparation for and conduct of a pilot study of the pharmacy MAT care model.
The aims of the first study phase (R21 grant) are:
- Aim 1: Develop a pharmacy CPA for the management of opioid use disorder using buprenorphine and naltrexone.
- Aim 2: For patient inmates maintained at the Rhode Island Department of Corrections, assess the feasibility and timing of randomization and transfer to a CPA pharmacy providing MAT post-release. This targeted assessment will inform the R33 design.
- Aim 3: Pilot test the pharmacy MAT model with up to 12 patients, assessing feasibility of medication dispensing, administration, and monitoring in the pharmacy, and determining patient acceptability of this model.
- Conditions
- Opioid-use Disorder
- Being tested
- Buprenorphine / Naloxone Oral Product, injectable naltrexone, Pharmacy maintenance addiction care
- 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
To treat opioid use disorder, buprenorphine/naloxone will be provided by a study pharmacist under a collaborative pharmacy practice agreement on a weekly (buprenorphine/naloxone) 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
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 on a stable dose of buprenorphine/naloxone or naltrexone will receive maintenance care at the pharmacy for one month. Patients will visit weekly for check-ins with a pharmacist. Patients on buprenorphine/naloxone will be dispensed their medication at study visits, whereas patients taking injectable naltrexone will be dispensed it once by the pharmacist during the pilot. All patients will visit the pharmacy at least weekly for addiction care (assessment, toxicological testing).
| Study group | Role | What they receive |
|---|---|---|
| Pharmacy based opioid use disorder care | Experimental | A single-arm pilot study to test the collaborative pharmacy practice agreement for MAT (using the medications buprenorphine or injectable naltrexone) care model with up to 12 patients with opioid use disorder, assessing feasibility of medication dispensing, administration, and monitoring in the pharmacy, and determining patient acceptability of this model. Receives: Drug: Buprenorphine / Naloxone Oral Product; Drug: injectable naltrexone; Other: Pharmacy maintenance addiction care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacists' dispensing of MAT medications
Measured by the number of MAT medications dispensed from a study pharmacy according to the pharmacy records, over the one month pilot period.
Measured: up to one month
Pharmacists' monitoring of MAT care
Measured by the number of toxicological drug screens performed at a study pharmacy over the one month pilot period.
Measured: up to one month
Pharmacist-reported feasibility of executing the collaborative pharmacy practice: agreement for MAT: Likert scale
7-point Likert scale item assessing the pharmacist's view of the overall model feasibility. The item asks: How acceptable is providing buprenorphine/Suboxone care at the pharmacy?
With responses ranging from 1 to 7 as:
- totally unacceptable
- unacceptable
- slightly unacceptable
- neutral
- slightly acceptable
- acceptable
- perfectly acceptable
Higher scores represent better outcome (i.e., endorsement of acceptability of the model), according to the pharmacists.
Measured: up to one month
Patient acceptability of pharmacy-provided MAT care: Likert scale
7-point Likert scale item assessing overall acceptability of the pharmacy MAT model. The item asks: How acceptable is going to the pharmacy for your buprenorphine/Suboxone care? With responses ranging from 1 to 7 as:
- totally unacceptable
- unacceptable
- slightly unacceptable
- neutral
- slightly acceptable
- acceptable
- perfectly acceptable
Higher scores represent better outcome (i.e., high endorsement of acceptability of the model), according to the patients.
Measured: up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start1 Sep 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lifespan
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rhode Island
- Responsible party
- Principal investigator, Traci Green, Lifespan
- Investigators
- Traci C Green, Principal investigator, Lifespan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766893
- Sponsor's protocol ID
- 1112133
- Acronym
- MATPharm
- Status last verified
- Jul 2019
- First submitted
- 2 Oct 2018
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. 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
- NCT03766893
- Acronym / sponsor ID
- MATPharm / 1112133
- Conditions
- Opioid-use Disorder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- LifespanUniversity, hospital or other
- Collaborators
- University of Rhode Island
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 6 Dec 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 examine how the pharmacy can better optimize treatment expansion by providing pharmacy-based medication assisted treatment (MAT) for maintenance under a collaborative pharmacy practice agreement.
Detailed description
This study will be the first to develop and use a collaborative pharmacy practice agreement (CPA) for medication assisted treatment (MAT) intended for statewide application. This will also 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 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 initial phase of the study (Phase 1) involves preparation for and conduct of a pilot study of the pharmacy MAT care model.
The aims of the first study phase (R21 grant) are:
- Aim 1: Develop a pharmacy CPA for the management of opioid use disorder using buprenorphine and naltrexone.
- Aim 2: For patient inmates maintained at the Rhode Island Department of Corrections, assess the feasibility and timing of randomization and transfer to a CPA pharmacy providing MAT post-release. This targeted assessment will inform the R33 design.
- Aim 3: Pilot test the pharmacy MAT model with up to 12 patients, assessing feasibility of medication dispensing, administration, and monitoring in the pharmacy, and determining patient acceptability of this model.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pharmacy based opioid use disorder care | Experimental | Drug: Buprenorphine / Naloxone Oral Product, Drug: injectable naltrexone, Other: Pharmacy maintenance addiction careA single-arm pilot study to test the collaborative pharmacy practice agreement for MAT (using the medications buprenorphine or injectable naltrexone) care model with up to 12 patients with opioid use disorder, assessing feasibility of medication dispensing, administration, and monitoring in the pharmacy, and determining patient acceptability of this model. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older;
- English speaking; currently enrolled at a CODAC site in Rhode Island for the treatment of opioid use disorder;
- maintained on a stable dose of buprenorphine or injectable naltrexone for at least 2 days;
- no stable co-morbid illnesses likely to progress clinically during the pilot study;
- able and willing to provide written informed consent and locator information (working telephone and >2 contacts) to participate.
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;
- any condition that, in the researchers' judgment, interferes with safe study participation or adherence to study procedures, including but not limited to a mental, medical or other substance use disorder that is likely to require ongoing, intense clinical management during the pilot study.
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 ProductTo treat opioid use disorder, buprenorphine/naloxone will be provided by a study pharmacist under a collaborative pharmacy practice agreement on a weekly (buprenorphine/naloxone) 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 based opioid use disorder care |
| injectable naltrexoneTo 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 based opioid use disorder care |
| Pharmacy maintenance addiction carePatients on a stable dose of buprenorphine/naloxone or naltrexone will receive maintenance care at the pharmacy for one month. Patients will visit weekly for check-ins with a pharmacist. Patients on buprenorphine/naloxone will be dispensed their medication at study visits, whereas patients taking injectable naltrexone will be dispensed it once by the pharmacist during the pilot. All patients will visit the pharmacy at least weekly for addiction care (assessment, toxicological testing). | Other | Pharmacy based opioid use disorder care |
Primary outcome
Pharmacists' dispensing of MAT medications
Time frame: up to one month
Measured by the number of MAT medications dispensed from a study pharmacy according to the pharmacy records, over the one month pilot period.
Pharmacists' monitoring of MAT care
Time frame: up to one month
Measured by the number of toxicological drug screens performed at a study pharmacy over the one month pilot period.
Pharmacist-reported feasibility of executing the collaborative pharmacy practice: agreement for MAT: Likert scale
Time frame: up to one month
7-point Likert scale item assessing the pharmacist's view of the overall model feasibility. The item asks: How acceptable is providing buprenorphine/Suboxone care at the pharmacy? With responses ranging from 1 to 7 as: 1. totally unacceptable 2. unacceptable 3. slightly unacceptable 4. neutral 5. slightly acceptable 6. acceptable 7. perfectly acceptable Higher scores represent better outcome (i.e., endorsement of acceptability of the model), according to the pharmacists.
Patient acceptability of pharmacy-provided MAT care: Likert scale
Time frame: up to one month
7-point Likert scale item assessing overall acceptability of the pharmacy MAT model. The item asks: How acceptable is going to the pharmacy for your buprenorphine/Suboxone care? With responses ranging from 1 to 7 as: 1. totally unacceptable 2. unacceptable 3. slightly unacceptable 4. neutral 5. slightly acceptable 6. acceptable 7. perfectly acceptable Higher scores represent better outcome (i.e., high endorsement of acceptability of the model), according to the patients.
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 1 Aug 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.
Traci C Green principal investigator
Lifespan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 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 5 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: finished, as of the sponsor's last update on 1 Aug 2019. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pharmacists' dispensing of MAT medications (time frame: up to one month). 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 1 Aug 2019.