Opioid Use Disorder Clinical Trial
— Pharm-OUD-CareOfficial title:
Buprenorphine Physician-Pharmacist Collaboration in the Management of Patients With Opioid Use Disorder: Clinical Trials Network 0075
Verified date | July 2021 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 71 |
Est. completion date | June 27, 2019 |
Est. primary completion date | June 27, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Changes by Choice | Durham | North Carolina |
United States | Clinic Pharmacy | Durham | North Carolina |
United States | Duke Outpatient Clinic | Durham | North Carolina |
United States | Josefs Pharmacy | Durham | North Carolina |
United States | Carolina Performance | Raleigh | North Carolina |
United States | Health Park Pharmacy | Raleigh | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University | National Institute on Drug Abuse (NIDA), The Emmes Company, LLC |
United States,
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 d — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Up to six months | |
Primary | Treatment Retention | Number of scheduled visits completed. | Up to six months | |
Primary | 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. | Up to six months | |
Primary | 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. | Up to six months | |
Secondary | 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. | Up to six months | |
Secondary | 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. | Up to six months | |
Secondary | 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. | Up to six months | |
Secondary | 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. | Up to six months |
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