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临床试验 NCT06316830 (Optimal Bup) 针对阿片类药物使用障碍目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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卡片视图
Identifying Optimal Buprenorphine Dosing for Opioid Use Disorder Treatment and Prevention of Overdose II期, III期 250 预防
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临床试验NCT06316830 (Optimal Bup)旨在研究治疗，主要针对阿片类药物使用障碍。这是一项II期 III期 干预性研究试验，目前试验状态为招募中。试验始于2025年1月6日，计划招募250名患者。该研究由Rhode Island Hospital主导，预计于2027年11月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年10月23日。
简要概括
The investigators aim to test the effectiveness of a high maintenance daily dose of buprenorphine (24 mg) for improving outcomes among patients who used fentanyl compared to the standard daily dose (16 mg).
The main question it aims to answer is: will patients who are randomly assigned to the high 24 mg maintenance dose, as compared to patients randomly assigned to the standard 16 mg maintenance dose, have improved ...
显示更多官方标题
Randomized Clinical Trial of a 16 mg vs. 24 mg Maintenance Daily Dose of Buprenorphine to Increase Retention in Treatment Among People With Opioid Use Disorder
疾病
阿片类药物使用障碍出版物
关于此临床试验发表的科学文章和研究论文：其他研究标识符
- Optimal Bup
- STUDY00000075
NCT编号
实际开始日期
2025-01-06
最近更新发布
2025-10-23
预计完成日期
2027-11-01
计划入组人数
250
研究类型
干预性研究
试验分期 (阶段)
II期
III期
III期
试验状态
招募中
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性High Maintenance Daily Dose (24mg) The experimental intervention is a high daily maintenance dose of buprenorphine (24 mg) plus any usual clinical care the participant receives at the clinic. This high daily dose is the upper limit of the FDA-approved dose range and was selected based on preclinical studies, clinician anecdotes, case reports, and retrospective analyses suggesting improved effectiveness of higher buprenorphine doses among patients with...显示更多 | Buprenorphine Buprenorphine in a highly effective treatment for opioid use disorder (OUD). Buprenorphine dose guidelines for OUD treatment were determined by clinical trials conducted in populations with a history of heroin use. However, fentanyl is changing the calculation of treatment, and optimal buprenorphine dosing for people who use fentanyl is unknown. |
阳性对照Standard Maintenance Daily Dose (16mg) The control intervention is the FDA-recommended target daily maintenance dose of buprenorphine (16 mg) plus any usual clinical care the participant receives at the clinic. | Buprenorphine Buprenorphine in a highly effective treatment for opioid use disorder (OUD). Buprenorphine dose guidelines for OUD treatment were determined by clinical trials conducted in populations with a history of heroin use. However, fentanyl is changing the calculation of treatment, and optimal buprenorphine dosing for people who use fentanyl is unknown. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Treatment Engagement | The primary outcome is the percentage of participants retained in buprenorphine treatment. Participants will be classified as retained in buprenorphine treatment at six months post- randomization if (1) the study site data indicate that they remained engaged in treatment or (2) the PDMP suggest that they continued treatment elsewhere and have not had a gap of more than 27 days in medication on-hand based on fill dates and days' supply. | six months post-randomization |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Control of Opioid Cravings | Measured using patient reported outcomes via the Opioid Craving Scale, a reliable, validated scale for people with opioid use disorder. The scale consists of three questions related to opioid cravings rated on a scale of 1-10 with 1 being not at all and 10 being extremely. A higher score denotes increased opioid cravings. | six months post-randomization |
Treatment response based on use of non-prescribed opioids | Non-prescribed fentanyl and other opioid use will be assessed via urine drug screens including fentanyl (UDS) and self-report. UDS will be assessed monthly for six months after study enrollment. Self-reported will be assessed at 1, 3, and 6 months via a Time Line Followback (TLFB) assessing ongoing non-prescribed opioid/fentanyl over the preceding two weeks. Based on UDS and self-reported data, participants will be classified as treatment responders if they have (1) no evidence (negative UDS and negative self-report) of non-prescribed opioid use at ≥1 assessment in months 1 to 3 AND (2) no evidence of non-prescribed opioid use at ≥2 assessments in months 4 to 6. | six months post-randomization |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- English-speaking
- Age 18 years-old or older
- Identified by the treating physician as having moderate to severe opioid use disorder (OUD)
- Initiating or continuing buprenorphine for treatment of opioid use disorder
- History of fentanyl use (confirmed by fentanyl positive urine drug screen (UDS) at intake OR if on buprenorphine maintenance treatment fentanyl plus a positive UDS within the last month OR self- reported ongoing fentanyl use during treatment)
- Previous enrollment in the trial
- Incarcerated or in police custody*
- Pregnant
- Live outside of Rhode Island (RI)
- Unable to provide informed consent
- Allergy to Buprenorphine
- Concomitant medication use deemed to present potential for serious medication interaction by the treating clinician *Participants that become incarcerated/or in police custody during the study will be withdrawn.
Rhode Island Hospital布朗大学研究责任方
Francesca Beaudoin, 主要研究者, Professor of Epidemiology and Emergency Medicine, Rhode Island Hospital
研究中心联系人
联系人: Jackie Goldman, 401-808-6950, [email protected]
联系人: Rachel Wightman, MD, [email protected]
1 位于 1 个国家/地区的研究中心
Rhode Island
Brown University, Providence, Rhode Island, 02912, United States
Jackie Goldman, 联系人, 401-808-6950, [email protected]
Francesca Beaudoin, 主要研究者
招募中