Back to resultsBuprenorphine Physician-Pharmacist Collaboration in the Management of Patients With Opioid Use Disorder: CTN 0075 (Pharm-OUD-Care)
Primary Purpose
Opioid Use Disorder
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
buprenorphine/naloxone
Pharmacist-administered buprenorphine/naloxone maintenance care
Sponsored by
About this trial
This is an interventional treatment trial for Opioid Use Disorder focused on measuring opioid use disorder, Medication-assisted treatment, Buprenorphine treatment, Collaborative care model
Eligibility Criteria
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.
Sites / Locations
- Duke Outpatient Clinic
- Josefs Pharmacy
- Changes by Choice
- Clinic Pharmacy
- Carolina Performance
- Health Park Pharmacy
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Pharmacy opioid use disorder care
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Treatment Retention
Number of scheduled visits completed.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT03248947
First Posted
August 10, 2017
Last Updated
July 26, 2021
Sponsor
Duke University
Collaborators
National Institute on Drug Abuse (NIDA), The Emmes Company, LLC
1. Study Identification
Unique Protocol Identification Number
NCT03248947
Brief Title
Buprenorphine Physician-Pharmacist Collaboration in the Management of Patients With Opioid Use Disorder: CTN 0075
Acronym
Pharm-OUD-Care
Official Title
Buprenorphine Physician-Pharmacist Collaboration in the Management of Patients With Opioid Use Disorder: Clinical Trials Network 0075
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
March 28, 2018 (Actual)
Primary Completion Date
June 27, 2019 (Actual)
Study Completion Date
June 27, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institute on Drug Abuse (NIDA), The Emmes Company, LLC
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder
Keywords
opioid use disorder, Medication-assisted treatment, Buprenorphine treatment, Collaborative care model
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pharmacy opioid use disorder care
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
buprenorphine/naloxone
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Pharmacist-administered buprenorphine/naloxone maintenance care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment Rate
Description
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.
Time Frame
Up to six months
Title
Treatment Retention
Description
Number of scheduled visits completed.
Time Frame
Up to six months
Title
Number of Participants With Opioid and Other Substance Use
Description
Measured via a composite of urine drug screen (UDS) and self-report via Timeline Follow-Back over 30 days.
Time Frame
Up to six months
Title
Number of Medication-Compliant Months Across All Participants
Description
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.
Time Frame
Up to six months
Secondary Outcome Measure Information:
Title
Treatment Fidelity
Description
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.
Time Frame
Up to six months
Title
Treatment Satisfaction
Description
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.
Time Frame
Up to six months
Title
Participant Safety
Description
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.
Time Frame
Up to six months
Title
Pharmacists' Use of the Prescription Drug Monitoring Program (PDMP)
Description
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.
Time Frame
Up to six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li-Tzy Wu, Sc.D.
Organizational Affiliation
Professor
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paolo Mannelli, M.D.
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Outpatient Clinic
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Josefs Pharmacy
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Changes by Choice
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Clinic Pharmacy
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Carolina Performance
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27615
Country
United States
Facility Name
Health Park Pharmacy
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27615
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33428284
Citation
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.
Results Reference
result
Learn more about this trial
Buprenorphine Physician-Pharmacist Collaboration in the Management of Patients With Opioid Use Disorder: CTN 0075
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