Oviedo-Joekes Eugenia, Marchand Kirsten, Lock Kurt, MacDonald Scott, Guh Daphne, Schechter Martin T
Centre for Health Evaluation & Outcome Sciences, Providence Health Care, St, Paul's Hospital, 575- 1081 Burrard St,, Vancouver, BC V6Z 1Y6, Canada.
Subst Abuse Treat Prev Policy. 2015 Jan 26;10:3. doi: 10.1186/1747-597X-10-3.
The Study to Assess Long-term Opioid Medication Effectiveness (SALOME) is a two-stage phase III, single site (Vancouver, Canada), randomized, double blind controlled trial designed to test if hydromorphone is as effective as diacetylmorphine for the treatment of long-term illicit opioid injection. Recruiting participants for clinical trials continues to be a challenge in medical and addiction research, with many studies not being able to reach the planned sample size in a timely manner. The aim of this study is to describe the recruitment strategies in SALOME, which offered appealing treatments but had limited clinic capacity and no guaranteed post-trial continuation of the treatments.
SALOME included chronic opioid-dependent, current illicit injection opioid users who had at least one previous episode of opioid maintenance treatment. Regulatory approvals were received in June 2011 and recruitment strategies were implemented over the next 5 months. Recruitment strategies included ongoing open communication with the community, a consistent and accessible team and participant-centered screening. All applicants completed a pre-screening checklist to assess prerequisites. Applicants meeting these prerequisites were later contacted to commence the screening process.
A total of 598 applications were received over the two-year recruitment period; 130 were received on the first day of recruitment. Of these applicants, 485 met prerequisites; however, many could not be found or were not reached before recruitment ended. For the 253 candidates who initiated the screening process, the average time lapse between application and screening date was 8.3 months (standard deviation [SD] = 4.44) and for the 202 randomized to the study, the average processing time from initial screen to randomization was 25.9 days (SD = 37.48; Median = 15.0).
As in prior trials offering injectable diacetylmorphine within a supervised model, recruiting participants for this study took longer than planned. The recruitment challenges overcome in SALOME were due to the high number of applicants compared with the limited number that could be randomized and treated. Our study emphasizes the value of integrating these strategies into clinical addiction research to overcome study-specific barriers.
ClinicalTrials.gov: NCT01447212.
评估长效阿片类药物疗效研究（SALOME）是一项两阶段的III期单中心（加拿大温哥华）随机双盲对照试验，旨在测试氢吗啡酮治疗长期非法阿片类药物注射是否与二乙酰吗啡同样有效。在医学和成瘾研究中，招募临床试验参与者仍然是一项挑战，许多研究无法及时达到计划的样本量。本研究的目的是描述SALOME的招募策略，该研究提供了有吸引力的治疗方法，但临床能力有限且无法保证试验后继续治疗。
SALOME纳入了慢性阿片类药物依赖的当前非法注射阿片类药物使用者，他们至少有过一次阿片类药物维持治疗经历。2011年6月获得监管批准，并在接下来的5个月内实施招募策略。招募策略包括与社区持续开放沟通、一个始终如一且易于联系的团队以及以参与者为中心的筛查。所有申请人都完成了一份预筛查清单以评估先决条件。符合这些先决条件的申请人随后被联系以开始筛查过程。
在为期两年的招募期内共收到598份申请；招募第一天收到130份。在这些申请人中，485人符合先决条件；然而，许多人在招募结束前找不到或无法联系到。对于开始筛查过程的253名候选人，申请到筛查日期的平均间隔时间为8.3个月（标准差[SD]=4.44），对于随机分组进入研究的202人，从初始筛查到随机分组的平均处理时间为25.9天（SD=37.48；中位数=15.0）。
与之前在监督模式下提供注射用二乙酰吗啡的试验一样，本研究招募参与者的时间比计划的要长。SALOME克服的招募挑战是由于申请人数量众多，而可随机分组和治疗的人数有限。我们的研究强调了将这些策略整合到临床成瘾研究中以克服特定研究障碍的价值。
ClinicalTrials.gov：NCT01447212。
