Pilot Study to Assess the Feasibility, Efficacy and Safety of Extended-release Injectable Buprenorphine for the Treatment of Opioid Use Disorder Among Individuals at High Risk of Overdose
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of XR-BUP injections received
研究概览
简要总结
This pilot study will evaluate the feasibility and clinical utility of extended-release injectable buprenorphine (XR-BUP) for the treatment of opioid use disorder (OUD) among individuals at high-risk for overdose (OD).
详细描述
FASTER-BUP is a 24-week observational pilot study evaluating the feasibility and clinical utility of XR-BUP (brand name: Sublocade) for the treatment of OUD among individuals at high-risk of OD. Forty participants with moderate to severe OUD starting treatment with XR-BUP as part of standard of care will be followed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet ALL the following criteria to be eligible to participate for the study:
- •Be above 19 years of age;
- •Be diagnosed with moderate or severe OUD as evidenced by their approval for treatment with XR-BUP (Sublocade);
- •Be at high-risk for recurrent overdose, defined as having experienced a recent non-fatal overdose within the past 6 months (e.g., admission to the emergency department for an overdose OR self-reported OD that required Naloxone administration OR had an overdose where an ambulance arrived at the scene);
- •Have a new prescription for XR-BUP, but have not yet initiated treatment;
- •Be able and willing to follow study procedures;
- •Be able to provide adequate locator information (e.g., phone number and at least one emergency contact);
- •Be able and willing to provide written informed consent;
- •Be able to understand, communicate and speak with the research staff. Non-English speaking individuals will require a translator to be present during all study visits and during all study activities. The translator will be independent (e.g., not known to the participant to prevent the risk for coercion or misrepresentation).
排除标准
- •Participants will be excluded from the study if ANY of the following criteria are met:
- •Be on OAT other than buprenorphine/naloxone in the 7 days prior to screening;
- •Be on a stable buprenorphine/naloxone dose for more than 27 days prior to screening;
- •Use of an investigational drug in the 30 days prior to screening;
- •Incarcerated, pending legal action or other reasons that might prevent completion of the study.
结局指标
主要结局
Number of XR-BUP injections received
时间窗: 24 weeks
The primary outcome for this study will be retention in treatment, defined as having received the six scheduled XR-BUP injections and completed the EOS/Early Termination visit.
Proportion of treatment-engaged visits per participant
时间窗: 24 weeks
Proportion of treatment-engaged visits per participant will be calculated as the number of received XR-BUP injections divided by the number of scheduled injections (i.e., six).
次要结局
- Safety monitoring(24 weeks)
- Percentage of opioid free weeks(24 weeks)
研究者
M. Eugenia Socias
Assistant Professor, Department of Medicine, UBC; Research Scientist, BCCSU
BC Centre on Substance Use