West China School of Medicine, Sichuan University, Chengdu, China.
Department of Anesthesiology and National Clinical Research Center for Geriatrics, West China Hospital, Sichuan University & The Research Units of West China (2018RU012, Chinese Academy of Medical Sciences), Chengdu, China.
J Addict Dis. 2022 Jul-Sep;40(3):394-404. doi: 10.1080/10550887.2021.2010972. Epub 2022 Mar 29.
Clinical trials drive the development of medicine. However, little is known about the current status of clinical trials on addiction. This study aimed to provide a comprehensive analysis of registered addiction-related trials from ClinicalTrials.gov.
We examined all addiction-related trials registered on ClinicalTrials.gov up to March 23, 2020. Statistical analysis was performed by using SPSS 25.0, and a two-sided < .05 was considered statistically significant.
370 eligible trials were identified. Over half of trials were completed, while only 13.8% of trials reported results. Sample sizes varied a lot with a median number of 84 per trial. Universities were the primary sponsor for 164 (44.3%) trials, followed by hospitals (96, 26.0%). Compared to trials without results, more trials with results were sponsored by universities (62.7% vs. 41.4%, = .003), and conducted in United States/Canada (90.2% vs. 48.3%, < .001). Most interventional trials were randomized with a parallel assignment, and 56.3% were blinded. Thirty one (41.3%) observational trials were cohort studies and 12 (16.0%) were case-only studies. Interventional trials were more likely to be funded by the US Government, while more observational trials were supported by industries. Trials funded by the US Government were more likely to be completed than those funded by other sources ( = .009).
Most registered trials on ClinicalTrials.gov about addiction were interventional trials with purpose for treatment. Most interventional trials were randomized, parallel, and masked. Our analysis highlighted the need for improvement in completing study results on the ClinicalTrials.gov.
临床试验推动医学发展。然而，目前对成瘾相关临床试验的现状知之甚少。本研究旨在对 ClinicalTrials.gov 上注册的成瘾相关试验进行全面分析。
我们检查了截至 2020 年 3 月 23 日在 ClinicalTrials.gov 上注册的所有成瘾相关试验。使用 SPSS 25.0 进行统计分析，双侧 <.05 被认为具有统计学意义。
确定了 370 项合格试验。超过一半的试验已经完成，而只有 13.8%的试验报告了结果。试验样本量差异很大，中位数为每个试验 84 个。大学是 164 项（44.3%）试验的主要赞助商，其次是医院（96 项，26.0%）。与未报告结果的试验相比，更多报告结果的试验由大学赞助（62.7%对 41.4%，=.003），且在美国/加拿大进行（90.2%对 48.3%，<.001）。大多数干预试验采用随机平行分配，56.3%为盲法。31 项（41.3%）观察性试验为队列研究，12 项（16.0%）为病例仅研究。干预试验更有可能由美国政府资助，而更多的观察性试验则由行业资助。由美国政府资助的试验比其他来源资助的试验更有可能完成（=.009）。
ClinicalTrials.gov 上注册的大多数成瘾相关试验是治疗目的的干预试验。大多数干预试验为随机、平行、盲法。我们的分析强调了在 ClinicalTrials.gov 上完成研究结果的必要性。
