Abstract：
BACKGROUND: There is little knowledge of the perspectives of people who use methamphetamine and have participated in clinical trials, and none for interventions not intended to address abstinence. A better understanding of these experiences could lead to more patient centred clinical trial design. This study seeks to understand the experiences of people who completed a clinical trial of lisdexamfetamine for the treatment of acute methamphetamine withdrawal.
METHODS: Thematic analysis of open-ended, semi-structured interviews with eight people who participated in an inpatient clinical trial of lisdexamfetamine for acute methamphetamine withdrawal. Interviews were conducted between days 3 and 6 of admission to an inner-city Sydney hospital.
RESULTS: Participants described how research procedures, the research setting, and the investigational product affected their experiences while enrolled in a clinical trial. Of particular importance to participants were transparent and low burden trial procedures, a welcoming trial environment, trusting relationships and effective communication, which were linked with the participants\' subsequent decision to remain enrolled in the trial.
CONCLUSIONS: The experiences of participants in this clinical trial can be distilled into four meta-themes: agency, caring-trust, safety, and communication. Participants spontaneously linked these experiences with a capacity to remain enrolled in the study. By considering the experiences of trial participants in clinical trial design, researchers can improve the experiences of future trial participants and facilitate their choice to remain enrolled in clinical trials.
METHODS: Thematic analysis of open-ended, semi-structured interviews with eight people who participated in an inpatient clinical trial of lisdexamfetamine for acute methamphetamine withdrawal. Interviews were conducted between days 3 and 6 of admission to an inner-city Sydney hospital.
RESULTS: Participants described how research procedures, the research setting, and the investigational product affected their experiences while enrolled in a clinical trial. Of particular importance to participants were transparent and low burden trial procedures, a welcoming trial environment, trusting relationships and effective communication, which were linked with the participants\' subsequent decision to remain enrolled in the trial.
CONCLUSIONS: The experiences of participants in this clinical trial can be distilled into four meta-themes: agency, caring-trust, safety, and communication. Participants spontaneously linked these experiences with a capacity to remain enrolled in the study. By considering the experiences of trial participants in clinical trial design, researchers can improve the experiences of future trial participants and facilitate their choice to remain enrolled in clinical trials.
摘要：
背景：对使用甲基苯丙胺并参加临床试验的人的观点知之甚少，对于不打算解决禁欲的干预措施，也没有。更好地理解这些经验可能会导致更多的以患者为中心的临床试验设计。这项研究旨在了解完成了利德西非他明治疗急性甲基苯丙胺戒断的临床试验的人们的经验。
方法：开放式主题分析，对8人进行了半结构化访谈，这些人参与了利德西非他明用于急性甲基苯丙胺戒断的住院临床试验。面试是在悉尼市中心医院入院的第3天至第6天进行的。
结果：参与者描述了研究程序，研究环境，研究产品影响了他们在参加临床试验时的经历。对参与者特别重要的是透明和低负担的审判程序，一个受欢迎的试验环境，信任关系和有效的沟通，这与参与者随后决定继续参加试验有关.
结论：这项临床试验参与者的经验可以归纳为四个元主题：机构，关怀信任，安全,和沟通。参与者自发地将这些经历与继续参与研究的能力联系起来。通过考虑临床试验设计中试验参与者的经验，研究人员可以改善未来试验参与者的体验,并帮助他们选择继续参加临床试验.
方法：开放式主题分析，对8人进行了半结构化访谈，这些人参与了利德西非他明用于急性甲基苯丙胺戒断的住院临床试验。面试是在悉尼市中心医院入院的第3天至第6天进行的。
结果：参与者描述了研究程序，研究环境，研究产品影响了他们在参加临床试验时的经历。对参与者特别重要的是透明和低负担的审判程序，一个受欢迎的试验环境，信任关系和有效的沟通，这与参与者随后决定继续参加试验有关.
结论：这项临床试验参与者的经验可以归纳为四个元主题：机构，关怀信任，安全,和沟通。参与者自发地将这些经历与继续参与研究的能力联系起来。通过考虑临床试验设计中试验参与者的经验，研究人员可以改善未来试验参与者的体验,并帮助他们选择继续参加临床试验.
