- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03248947
Buprenorphine Physician-Pharmacist Collaboration in the Management of Patients With Opioid Use Disorder: CTN 0075 (Pharm-OUD-Care)
July 26, 2021 updated by: Duke University
Buprenorphine Physician-Pharmacist Collaboration in the Management of Patients With Opioid Use Disorder: Clinical Trials Network 0075
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
71
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27704
- Duke Outpatient Clinic
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Durham, North Carolina, United States, 27704
- Josefs Pharmacy
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Durham, North Carolina, United States, 27705
- Changes by Choice
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Durham, North Carolina, United States, 27705
- Clinic Pharmacy
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Raleigh, North Carolina, United States, 27615
- Health Park Pharmacy
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Raleigh, North Carolina, United States, 27615
- Carolina Performance
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Pharmacy opioid use disorder care
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.
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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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recruitment Rate
Time Frame: Up to six months
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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.
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Up to six months
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Treatment Retention
Time Frame: Up to six months
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Number of scheduled visits completed.
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Up to six months
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Number of Participants With Opioid and Other Substance Use
Time Frame: Up to six months
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Measured via a composite of urine drug screen (UDS) and self-report via Timeline Follow-Back over 30 days.
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Up to six months
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Number of Medication-Compliant Months Across All Participants
Time Frame: Up to six months
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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.
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Up to six months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment Fidelity
Time Frame: Up to six months
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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.
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Up to six months
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Treatment Satisfaction
Time Frame: Up to six months
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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.
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Up to six months
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Participant Safety
Time Frame: Up to six months
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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.
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Up to six months
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Pharmacists' Use of the Prescription Drug Monitoring Program (PDMP)
Time Frame: Up to six months
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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.
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Up to six months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Li-Tzy Wu, Sc.D., Professor
- Principal Investigator: Paolo Mannelli, M.D., Associate Professor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 28, 2018
Primary Completion (Actual)
June 27, 2019
Study Completion (Actual)
June 27, 2019
Study Registration Dates
First Submitted
August 10, 2017
First Submitted That Met QC Criteria
August 10, 2017
First Posted (Actual)
August 15, 2017
Study Record Updates
Last Update Posted (Actual)
July 28, 2021
Last Update Submitted That Met QC Criteria
July 26, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Pathologic Processes
- Narcotic-Related Disorders
- Substance-Related Disorders
- Disease
- Opioid-Related Disorders
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Narcotic Antagonists
- Buprenorphine
- Naloxone
- Buprenorphine, Naloxone Drug Combination
Other Study ID Numbers
- Pro00083544
- UG1DA040317 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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