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Trial record 78 of 186 for:    BUPRENORPHINE AND NALOXONE

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
Last Update Posted : July 12, 2019
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
The Emmes Company, LLC
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Opioid Use Disorder Drug: buprenorphine/naloxone Other: Pharmacist-administered buprenorphine/naloxone maintenance care Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Buprenorphine Physician-Pharmacist Collaboration in the Management of Patients With Opioid Use Disorder: Clinical Trials Network 0075
Actual Study Start Date : March 28, 2018
Actual Primary Completion Date : June 27, 2019
Actual Study Completion Date : June 27, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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.

  2. Treatment retention [ Time Frame: Up to six months ]
    Proportion of scheduled visits completed.

  3. 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.

  4. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248947


Locations
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United States, North Carolina
Duke Outpatient Clinic
Durham, North Carolina, United States, 27704
Josefs Pharmacy
Durham, North Carolina, United States, 27704
Changes by Choice
Durham, North Carolina, United States, 27705
Clinic Pharmacy
Durham, North Carolina, United States, 27705
Carolina Performance
Raleigh, North Carolina, United States, 27615
Health Park Pharmacy
Raleigh, North Carolina, United States, 27615
Sponsors and Collaborators
Duke University
National Institute on Drug Abuse (NIDA)
The Emmes Company, LLC
Investigators
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Principal Investigator: Li-Tzy Wu, Sc.D. Professor
Principal Investigator: Paolo Mannelli, M.D. Associate Professor

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03248947     History of Changes
Other Study ID Numbers: Pro00083544
UG1DA040317 ( U.S. NIH Grant/Contract )
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Duke University:
opioid use disorder
Medication-assisted treatment
Buprenorphine treatment
Collaborative care model
Additional relevant MeSH terms:
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Buprenorphine
Buprenorphine, Naloxone Drug Combination
Naloxone
Disease
Substance-Related Disorders
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists