Buprenorphine Physician-Pharmacist Collaboration in the Management of Patients With Opioid Use Disorder: Clinical Trials Network 0075
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 6
- 主要终点
- Recruitment Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: buprenorphine/naloxone (Drug)
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.
干预措施: Pharmacist-administered buprenorphine/naloxone maintenance care (Other)
结局指标
主要结局
Recruitment Rate
时间窗: 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
时间窗: Up to six months
Number of scheduled visits completed.
Number of Participants With Opioid and Other Substance Use
时间窗: 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
时间窗: 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.
次要结局
- Treatment Fidelity(Up to six months)
- Treatment Satisfaction(Up to six months)
- Participant Safety(Up to six months)
- Pharmacists' Use of the Prescription Drug Monitoring Program (PDMP)(Up to six months)