Opioid Use DisorderEarly Phase 1Pharm-OUD-CareNCT03248947

Buprenorphine Physician-Pharmacist Collaboration in the Management of Patients With Opioid Use Disorder: CTN 0075

A Early Phase 1 study testing buprenorphine/naloxone and Pharmacist-administered buprenorphine/naloxone maintenance care in people with Opioid Use Disorder, run by Duke University at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This pilot study examines the feasibility and acceptability of transitioning office-based buprenorphine treatment of opioid use disorder from physicians to pharmacists. Results from this study will inform the development of a future multi-site randomized clinical trial. 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 and Pharmacist-administered buprenorphine/naloxone maintenance care
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 71 participants
Where: 6 sitesUnited States
Study dates: 28 Mar 2018to 27 Jun 2019
Phase: Early Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Be adults aged 18 years or older.
If female, use adequate birth control methods.
Meet DSM-5 criteria for past-year OUD and have completed buprenorphine induction for OUD.
Have expressed the intention to receive maintenance (≥6 months) buprenorphine treatment.
Be willing to receive pharmacist administered buprenorphine maintenance treatment
Be willing and able to provide written informed consent and HIPAA authorization.
Be able to read and communicate in English.
Be able to comply with buprenorphine treatment policies.

Who cannot join

Have a serious medical, psychiatric or substance use disorder that, in the opinion of the study physician, would make study participation hazardous to the participant, compromise study findings, or prevent the participant from completing the study.
Have known allergy or hypersensitivity to buprenorphine, naloxone, or other components of the buprenorphine/naloxone formulation.
Have aspartate aminotransferase (AST) or alanine aminotransferase (ALT) liver enzymes greater than 5 times the upper limit of normal on screening phlebotomy performed within 60 days prior to the date of the last stabilization visit.
Have chronic pain requiring ongoing pain management with opioid analgesics.
Pending legal action or other reasons that might prevent an individual from completing the study (i.e., unable to complete 6 months of pharmacy-based OUD management).
Pregnant or breastfeeding at the time of screening.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Duke Outpatient Clinic
Durham, North Carolina, 27704
Josefs Pharmacy
Durham, North Carolina, 27704
Changes by Choice
Durham, North Carolina, 27705
Clinic Pharmacy
Durham, North Carolina, 27705
Carolina Performance
Raleigh, North Carolina, 27615
Health Park Pharmacy
Raleigh, North Carolina, 27615

Other trials in United States

About this study

Official title: Buprenorphine Physician-Pharmacist Collaboration in the Management of Patients With Opioid Use Disorder: Clinical Trials Network 0075

Read the detailed description

The overall objective of this study is to explore the feasibility of transitioning the care of adult patients with opioid use disorder (OUD) who receive office-based buprenorphine treatment (OBBT) from physicians to pharmacists. Physicians will induce buprenorphine treatment and complete the stabilization phase before referring patients to pharmacists for the management of monthly maintenance visits. This study will assess the feasibility and acceptability of a collaborative care model between physician and pharmacist by measuring recruitment rate, treatment retention rate, treatment compliance rate, and participants' substance use. Other assessments measured will include treatment fidelity, participant, physician, and pharmacist satisfaction with OUD care, participant safety, and the pharmacists' use of electronic health records and the Prescription Drug Monitoring Program.

Conditions: Opioid Use Disorder
Being tested: buprenorphine/naloxone, Pharmacist-administered buprenorphine/naloxone maintenance care
Keywords: opioid use disorder, Medication-assisted treatment, Buprenorphine treatment, Collaborative care model
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/naloxoneDrug
To relieve opioid withdrawal symptoms and craving, buprenorphine/naloxone will be prescribed by the study-physician and dispensed by the study-pharmacist on a monthly basis. The median expected dose is 16 mg daily, though adjustment by the study physician may be needed due to increased withdrawal and craving from previous study visits. Medication will be provided in the form of a sublingual film.
Pharmacist-administered buprenorphine/naloxone maintenance careOther
Following buprenorphine/naloxone induction/stabilization with the physician, participants with opioid use disorder will be transferred to the care of pharmacists for the maintenance phase of treatment. Maintenance visits will occur monthly with the pharmacist at the pharmacy location for six months. Buprenorphine/naloxone will be dispensed by the pharmacist at the monthly study visits following participant assessment, communication with the physician, and prescription form the physician.

Study groups in NCT03248947
Study group	Role	What they receive
Pharmacy opioid use disorder care	Other	A single-arm study to evaluate the feasibility and acceptability of transitioning office-based buprenorphine treatment of adult patients with opioid use disorder from physicians to pharmacists. Receives: Drug: buprenorphine/naloxone; Other: Pharmacist-administered buprenorphine/naloxone maintenance care

What is being measured

The primary outcome is the main question the study is designed to answer.

Recruitment Rate
Measured by a composite of the number of participants with opioid use disorder recruited (i.e., signed the informed consent form) per month, and by site and the average monthly rate of participants enrolled among potential participants who were screened.
Measured: Up to six months
Treatment Retention
Number of scheduled visits completed.
Measured: Up to six months
Number of Participants With Opioid and Other Substance Use
Measured via a composite of urine drug screen (UDS) and self-report via Timeline Follow-Back over 30 days.
Measured: Up to six months
Number of Medication-Compliant Months Across All Participants
Medication compliance is defined as taking any of the dispensed medication during the past month as measured by pill count/dose reconciliation at each study visit. Medication compliance is calculated as the percentage of compliant months out of the overall number of expected study months.
Measured: Up to six months

Secondary outcomes (4)

Treatment Fidelity
Number of monitored study visits with physicians and pharmacists showing 80% adherence or higher to study specific tasks and responsibilities. Adherence will be calculated as the number of items completed on the Buprenorphine Visit Checklist divided by the sum of the number of complete and incomplete items.
Measured: Up to six months
Treatment Satisfaction
Indicators of satisfaction with treatment delivery measured by participants, pharmacists, and physicians using the Treatment Satisfaction Scale after each study visit. A score of 5=very satisfied, 4=satisfied, 3=neither satisfied or dissatisfied, 2=dissatisfied, and 1=very dissatisfied.
Measured: Up to six months
Participant Safety
A composite of self-report and medical record abstraction to measure any fatal or non-fatal opioid overdose and any opioid or other substance-related emergency department visit or hospitalization.
Measured: Up to six months
Pharmacists' Use of the Prescription Drug Monitoring Program (PDMP)
Measured at each study visit via an action item checklist to confirm whether the PDMP was inquired to identify the following for each participant: measures of multiple buprenorphine prescriptions, any prescriptions for class II and III medications, and any other information that may be useful for the participant's treatment such as documented drug-related medical interventions or disciplinary charges.
Measured: Up to six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Mar 201827 Jun 2019

First posted15 Aug 2017
Study start28 Mar 2018
Primary completion27 Jun 2019
Study completion27 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
More trials run by Duke 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: Early Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 71 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03248947
Sponsor's protocol ID: Pro00083544
Other IDs: UG1DA040317
Acronym: Pharm-OUD-Care
Status last verified: Jul 2021
First submitted: 10 Aug 2017
Last updated: 28 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Wu LT, John WS, Ghitza UE, Wahle A, Matthews AG, Lewis M, Hart B, Hubbard Z, Bowlby LA, Greenblatt LH, Mannelli P; Pharm-OUD-Care Collaborative Investigators. Buprenorphine physician-pharmacist collaboration in the management of patients with opioid use disorder: results from a multisite study of the National Drug Abuse Treatment Clinical Trials Network. Addiction. 2021 Jul;116(7):1805-1816. doi: 10.1111/add.15353. Epub 2021 Jan 11.
PubMed 33428284

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Recruiting
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All Opioid Use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Buprenorphine Physician-Pharmacist Collaboration in the Management of Patients With Opioid Use Disorder: Clinical Trials Network 0075
ClinicalTrials.gov ID: NCT03248947
Acronym / sponsor ID: Pharm-OUD-Care / Pro00083544
Conditions: Opioid Use Disorder
Keywords: opioid use disorder, Medication-assisted treatment, Buprenorphine treatment, Collaborative care model
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 71 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA), The Emmes Company, LLC
Study start: 28 Mar 2018 (actual)
Primary completion: 27 Jun 2019 (actual)
Study completion: 27 Jun 2019 (actual)
First posted: 15 Aug 2017 (actual)
Results: Posted 10 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Pharmacy opioid use disorder care	Other	Drug: buprenorphine/naloxone, Other: Pharmacist-administered buprenorphine/naloxone maintenance careA single-arm study to evaluate the feasibility and acceptability of transitioning office-based buprenorphine treatment of adult patients with opioid use disorder from physicians to pharmacists.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Be adults aged 18 years or older.
If female, use adequate birth control methods.
Meet DSM-5 criteria for past-year OUD and have completed buprenorphine induction for OUD.
Have expressed the intention to receive maintenance (≥6 months) buprenorphine treatment.
Be willing to receive pharmacist administered buprenorphine maintenance treatment

Key exclusion criteria (6 listed)

Have a serious medical, psychiatric or substance use disorder that, in the opinion of the study physician, would make study participation hazardous to the participant, compromise study findings, or prevent the participant from completing the study.
Have known allergy or hypersensitivity to buprenorphine, naloxone, or other components of the buprenorphine/naloxone formulation.
Have aspartate aminotransferase (AST) or alanine aminotransferase (ALT) liver enzymes greater than 5 times the upper limit of normal on screening phlebotomy performed within 60 days prior to the date of the last stabilization visit.
Have chronic pain requiring ongoing pain management with opioid analgesics.
Pending legal action or other reasons that might prevent an individual from completing the study (i.e., unable to complete 6 months of pharmacy-based OUD 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/naloxoneTo relieve opioid withdrawal symptoms and craving, buprenorphine/naloxone will be prescribed by the study-physician and dispensed by the study-pharmacist on a monthly basis. The median expected dose is 16 mg daily, though adjustment by the study physician may be needed due to increased withdrawal and craving from previous study visits. Medication will be provided in the form of a sublingual film.	Drug	Pharmacy opioid use disorder care
Pharmacist-administered buprenorphine/naloxone maintenance careFollowing buprenorphine/naloxone induction/stabilization with the physician, participants with opioid use disorder will be transferred to the care of pharmacists for the maintenance phase of treatment. Maintenance visits will occur monthly with the pharmacist at the pharmacy location for six months. Buprenorphine/naloxone will be dispensed by the pharmacist at the monthly study visits following participant assessment, communication with the physician, and prescription form the physician.	Other	Pharmacy opioid use disorder care

Primary outcome

Recruitment Rate
Time frame: Up to six months
Measured by a composite of the number of participants with opioid use disorder recruited (i.e., signed the informed consent form) per month, and by site and the average monthly rate of participants enrolled among potential participants who were screened.
Treatment Retention
Time frame: Up to six months
Number of scheduled visits completed.
Number of Participants With Opioid and Other Substance Use
Time frame: Up to six months
Measured via a composite of urine drug screen (UDS) and self-report via Timeline Follow-Back over 30 days.
Number of Medication-Compliant Months Across All Participants
Time frame: Up to six months
Medication compliance is defined as taking any of the dispensed medication during the past month as measured by pill count/dose reconciliation at each study visit. Medication compliance is calculated as the percentage of compliant months out of the overall number of expected study months.

4 secondary outcomes

Treatment Fidelity
Time frame: Up to six months
Treatment Satisfaction
Time frame: Up to six months
Participant Safety
Time frame: Up to six months
Pharmacists' Use of the Prescription Drug Monitoring Program (PDMP)
Time frame: Up to six months

Results and safety

Results posted to the registry on 10 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pharmacist-administered Buprenorphine Maintenance Care	71	63

Primary outcome: Recruitment Rate

Time frame: Up to six months. Count of participants. Unit: Participants

Measure	Pre-screened Participants n = 92	Consented Participants n = 76
Pre-screened participants consented	76	NA
Consented participants enrolled into study	NA	71

Primary outcome: Treatment Retention

Time frame: Up to six months. Count of units. Unit: Visits

Measure	Pharmacist-administered Buprenorphine Maintenance Care n = 71
Value	406

Population analysed: The number of expected study visits for each participant is 6, based on 1 visit per month for the 6 months of the study arm. The overall number of expected study visits for all participants is 426, based on 6 visits per participant multiplied by 71 participants in the study arm.

Primary outcome: Number of Participants With Opioid and Other Substance Use

Time frame: Up to six months. Count of participants. Unit: Participants

Measure	Pharmacist-administered Buprenorphine Maintenance Care n = 71
Positive opioid UDS at month 6	10
Positive other substance UDS at month 6	38
Self-reported opioid use at month 6	10

Population analysed: Missing UDS imputed as positive

Primary outcome: Number of Medication-Compliant Months Across All Participants

Time frame: Up to six months. Count of units. Unit: Months

Measure	Pharmacist-administered Buprenorphine Maintenance Care n = 71
Value	406

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pharmacist-administered Buprenorphine Maintenance Care	2 of 71 (2.8%)	0 of 71 (0%)	0 of 71

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 33428284Wu LT, John WS, Ghitza UE, Wahle A, Matthews AG, Lewis M, Hart B, Hubbard Z, Bowlby LA, Greenblatt LH, Mannelli P; Pharm-OUD-Care Collaborative Investigators. Buprenorphine physician-pharmacist collaboration in the management of patients with opioid use disorder: results from a multisite study of the National Drug Abuse Treatment Clinical Trials Network. Addiction. 2021 Jul;116(7):1805-1816. doi: 10.1111/add.15353. Epub 2021 Jan 11.
Individual participant dataSharing planned: Undecided

Related trials for Opioid Use Disorder

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Enrolling by invitationObservational study
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Recruiting
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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.

Li-Tzy Wu, Sc.D. principal investigator

Professor

Paolo Mannelli, M.D. principal investigator

Associate Professor

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 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 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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.

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?

Yes. Results are posted in the registry (first posted 10 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Recruitment Rate (time frame: Up to six months). 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?

On the ClinicalTrials.gov record for NCT03248947, 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 28 Jul 2021.