A randomized clinical trial of a theory-based fentanyl overdose education and fentanyl test strip distribution intervention to reduce rates of opioid overdose: study protocol for a randomized controlled trial.
A randomized clinical trial of a theory-based fentanyl overdose education and fentanyl test strip distribution intervention to reduce rates of opioid overdose: study protocol for a randomized controlled trial.
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DOI：
10.1186/s13063-020-04898-8
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发表时间：
2020-11-26
期刊：
影响因子：
2.5
通讯作者：
Marshall BDL
中科院分区：
文献类型：
--
作者：
Jacka BP;Goldman JE;Yedinak JL;Bernstein E;Hadland SE;Buxton JA;Sherman SG;Biello KB;Marshall BDL
涉及合成类阿片，特别是非法制造的芬太尼的类阿片过量死亡仍然是北美的一个重大公共卫生问题。对用药过量事件的反应（例如，纳洛酮给药和人工呼吸）可有效降低死亡率;然而，需要更多的干预措施来防止涉及非法制造的芬太尼的过量。本研究方案旨在评估行为改变干预的有效性，该干预包括个人咨询，芬太尼试纸使用的实践培训，以及在吸毒者中分发芬太尼试纸供带回家使用。将通过广告和有针对性的街头外展招募报告近期使用药物（包括从街头获得的处方药;海洛因、可卡因粉、快克可卡因、甲基苯丙胺或任何注射药物）的18-65岁的罗得岛居民（n = 500），进行一项双臂随机临床试验，随机化后随访12个月。合格的受试者将随机（1：1）接受急流干预（即，芬太尼特定的过量教育，行为改变动机访谈（MI）会议，重点是使用芬太尼测试条，以减少过量风险，芬太尼测试条培训，并分发芬太尼测试条供个人使用）或标准过量教育作为对照。受试者将在随机化后1、2和3个月参加MI强化治疗（干预）或注意力匹配对照治疗。所有参与者将在入组时提供纳洛酮。主要结局是6个月和/或12个月随访访视时前一个月自我报告的药物过量的复合指标。次要结局指标包括与致死性（尸检）和非致死性（住院或紧急医疗服务利用）药物过量相关的管理相关数据。如果急流干预措施有效，其简短的MI和芬太尼测试条培训内容可以很容易地纳入现有的基于社区的过量预防计划，以帮助降低芬太尼相关阿片类药物过量的发生率。ClinicalTrials.gov NCT 04372238。注册日期：2020年5月1日
Opioid overdose deaths involving synthetic opioids, particularly illicitly manufactured fentanyl, remain a substantial public health concern in North America. Responses to overdose events (e.g., administration of naloxone and rescue breathing) are effective at reducing mortality; however, more interventions are needed to prevent overdoses involving illicitly manufactured fentanyl. This study protocol aims to evaluate the effectiveness of a behavior change intervention that incorporates individual counseling, practical training in fentanyl test strip use, and distribution of fentanyl test strips for take-home use among people who use drugs. Residents of Rhode Island aged 18–65 years who report recent substance use (including prescription pills obtained from the street; heroin, powder cocaine, crack cocaine, methamphetamine; or any drug by injection) (n = 500) will be recruited through advertisements and targeted street-based outreach into a two-arm randomized clinical trial with 12 months of post-randomization follow-up. Eligible participants will be randomized (1:1) to receive either the RAPIDS intervention (i.e., fentanyl-specific overdose education, behavior change motivational interviewing (MI) sessions focused on using fentanyl test strips to reduce overdose risk, fentanyl test strip training, and distribution of fentanyl test strips for personal use) or standard overdose education as control. Participants will attend MI booster sessions (intervention) or attention-matched control sessions at 1, 2, and 3 months post-randomization. All participants will be offered naloxone at enrolment. The primary outcome is a composite measure of self-reported overdose in the previous month at 6- and/or 12-month follow-up visit. Secondary outcome measures include administratively linked data regarding fatal (post-mortem investigation) and non-fatal (hospitalization or emergency medical service utilization) overdoses. If the RAPIDS intervention is found to be effective, its brief MI and fentanyl test strip training components could be easily incorporated into existing community-based overdose prevention programming to help reduce the rates of fentanyl-related opioid overdose. ClinicalTrials.gov NCT04372238. Registered on 01 May 2020
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