Improving Buprenorphine Initiation Among Individuals With Opioid Use Disorder Using Fentanyl
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Continuous retention in outpatient buprenorphine treatment by day 90
研究概览
简要总结
The goal of this pragmatic randomized controlled trial is to compare treatment outcomes of two strategies for initiating buprenorphine treatment (low-dose initiation and direct-to-inject) in adults with opioid use disorder (OUD) who use fentanyl. This study aims to:
- Compare effectiveness of each strategy on treatment retention in a real world, clinical setting, and
- Assess differences between strategies in patient-reported outcomes, including withdrawal symptoms, cravings, drug use, treatment satisfaction, and overall acceptability.
Participants will:
- Be randomized to initiate buprenorphine via a low-dose initiation or direct-to-inject protocol at an outpatient buprenorphine clinic,
- Keep a diary of craving and withdrawal symptoms for the first 7 days after initiation, and
- Visit the outpatient clinic 7, 30, and 90 days after initiation for urinary drug screen and follow-up surveys.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Age ≥ 18 years of age at Visit
- •Documentation of an OUD diagnosis as evidenced by meeting two or more of the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) Criteria for Opioid Use Disorder
- •Self-reported daily use of fentanyl ≥ 5 out of the past 7 days at baseline,
- •Fentanyl-positive urine drug screening at baseline,
- •Interest in stopping or reducing fentanyl use,
- •Publicly insured through San Francisco Medicaid or Medicare and therefore able receive buprenorphine prescription dispensing through Community Behavioral Health Services (CBHS) Pharmacy
排除标准
- •Currently nursing, pregnant, or anticipating pregnancy in the next 6 months
- •Methadone-positive urine drug screening at baseline
- •Buprenorphine-positive urine drug screening at baseline
- •Be unable to provide any locator or contact information at least one contact in addition to themselves
- •Any pending legal action that could prevent participation in study activities
- •Presence of a condition or abnormality that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data (e.g., acute psychosis), or cognitive impairment (e.g., dementia)
研究组 & 干预措施
Low-dose initiation (LDI)
Participants start 0.5mg sublingual buprenorphine (Subutex) and gradually increase by 0.5-1.0mg daily for 7 days
干预措施: Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets) (Drug)
Direct-to-inject (DTI)
Participants receive 8-32mg long-acting injectable buprenorphine (Brixadi or Sublocade) on day 1, followed by monthly injections as discussed with the provider
干预措施: Injectable buprenorphine (Drug)
结局指标
主要结局
Continuous retention in outpatient buprenorphine treatment by day 90
时间窗: 90 days
Receiving continuous treatment with buprenorphine sublingual prescriptions or injections administrations during the 90 days of follow up post-randomization as intended-to-treat. A period without buprenorphine treatment ≥8 days will be considered treatment discontinuation. Number of days of continuous treatment with the site clinician prescribing sublingual or injectable buprenorphine treatment during the 90 days post-randomization among RCT participants
Self-reported protocol satisfaction at day 7
时间窗: 7 days
Patient-reported satisfaction with buprenorphine initiation protocol measured by Likert-scale satisfaction survey administered on day 7 follow-up visit
次要结局
- Per protocol and as-treated retention in outpatient buprenorphine treatment at day 90(90 days)
- Successful buprenorphine initiation within first 7 days(7 days)
- Fentanyl use during days 1-7 determiend by urinary drug screen(7 days)
- Fentanyl use during days 8-30 determined by urinary drug screen(30 days)
- Fentanyl use during days 31-90 determined by urinary drug screen(90 days)
- Self-reported concurrent fentanyl use during days 1-7(7 days)
- Self-reported concurrent fentanyl use during days 8-30(30 days)
- Self-reported concurrent fentanyl use during days 31-90(90 days)
- Self-reported number of days of fentanyl use in first 7 days(7 days)
- Self-reported number of days of concurrent fentanyl use during first 30 days(30 days)
- Self-reported number of days of concurrent fentanyl use during days 31-90(90 days)
- Baseline withdrawal symptoms, measured with COWS(0 days)
- Standardized self-reported daily withdrawal symptom severity over days 1-7 by SOWS(7 days)
- Standardized self-reported peak withdrawal symptom severity during days 1-7 by SOWS(7 days)
- Standardized self-reported daily craving symptom severity over days 1-7 by VAS(7 days)
- Standardized self-reported peak craving symptom severity during days 1-7 by VAS(7 days)