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Buprenorphine Physician-Pharmacist Collaboration in the Management of Patients With Opioid Use Disorder: CTN 0075 (Pharm-OUD-Care)

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ClinicalTrials.gov Identifier: NCT03248947
Recruitment Status : Completed
First Posted : August 15, 2017
Results First Posted : August 10, 2020
Last Update Posted : July 28, 2021
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
The Emmes Company, LLC
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE August 10, 2017
First Posted Date  ICMJE August 15, 2017
Results First Submitted Date  ICMJE June 18, 2020
Results First Posted Date  ICMJE August 10, 2020
Last Update Posted Date July 28, 2021
Actual Study Start Date  ICMJE March 28, 2018
Actual Primary Completion Date June 27, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2021)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 10, 2017)
  • 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 ]
    Proportion of scheduled visits completed.
  • Opioid and other substance use [ Time Frame: Up to six months ]
    Measured via a composite of urine drug screen and self-report via Timeline Follow-Back over 30 days.
  • Medication compliance [ Time Frame: Up to six months ]
    Measured by pill count/dose reconciliation at each visit (proportion of expected buprenorphine use in relation to actual use).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2021)
  • Treatment Fidelity [ Time Frame: Up to six months ]
    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 [ Time Frame: Up to six months ]
    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 [ Time Frame: Up to six months ]
    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) [ Time Frame: Up to six months ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2017)
  • Treatment fidelity [ Time Frame: Up to six months ]
    Proportion of study visits with physicians and pharmacists showing 80% adherence or higher to study specific tasks and responsibilities.
  • Treatment satisfaction [ Time Frame: Up to six months ]
    Indicators of satisfaction with treatment delivery measured by participants, pharmacists, and physicians using the Treatment Satisfaction Scale after each study visit: proportion of visits in which all raters are satisfied (score of 4 on a Likert Scale of 1-5) or extremely satisfied (score of 5 on a Likert Scale of 1-5).
  • Participant safety [ Time Frame: Up to six months ]
    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) [ Time Frame: Up to six months ]
    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.
  • Pharmacists' use of electronic health records (EHRs) [ Time Frame: Up to six months ]
    Access to participant's EHRs will be measured at each study visit via an action item checklist. Depending on access, EHR data will be compared with other outcome measures and data collected from the PDMP.
  • Use of the EHR to compare treatment outcome measures [ Time Frame: Up to six months ]
    EHR data will be abstracted from matched non-pharmacy treated patients with opioid use disorder to compare outcomes.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Buprenorphine Physician-Pharmacist Collaboration in the Management of Patients With Opioid Use Disorder: CTN 0075
Official Title  ICMJE Buprenorphine Physician-Pharmacist Collaboration in the Management of Patients With Opioid Use Disorder: Clinical Trials Network 0075
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Opioid Use Disorder
Intervention  ICMJE
  • Drug: buprenorphine/naloxone
    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.
  • Other: Pharmacist-administered buprenorphine/naloxone maintenance care
    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 Arms  ICMJE 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.
Interventions:
  • Drug: buprenorphine/naloxone
  • Other: Pharmacist-administered buprenorphine/naloxone maintenance care
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 26, 2019)
71
Original Estimated Enrollment  ICMJE
 (submitted: August 10, 2017)
70
Actual Study Completion Date  ICMJE June 27, 2019
Actual Primary Completion Date June 27, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03248947
Other Study ID Numbers  ICMJE Pro00083544
UG1DA040317 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE
  • National Institute on Drug Abuse (NIDA)
  • The Emmes Company, LLC
Investigators  ICMJE
Principal Investigator: Li-Tzy Wu, Sc.D. Professor
Principal Investigator: Paolo Mannelli, M.D. Associate Professor
PRS Account Duke University
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP