Faculty of Human Sciences, University of Tsukuba, 3-29-1 Otsuka, Bunkyo-ku, Tokyo, 112-0012, Japan.
National Center for Global Health and Medicine, Tokyo, Japan.
Trials. 2021 Dec 11;22(1):909. doi: 10.1186/s13063-021-05882-6.
The Philippines has been severely affected by the methamphetamine crisis. The government has launched a policy war against drug use, although the severe sanctions imposed on drug users have been criticized internationally. To help implement a more effective and humane approach to drug use, this study aimed to introduce a comprehensive treatment program for methamphetamine users based on cognitive-behavioral therapy (CBT) whose effectiveness will be evaluated through a randomized controlled trial.
Methamphetamine users admitted into government-run rehabilitation facilities are recruited and randomly assigned to either a CBT-based treatment program or existing therapeutic community (TC)-based treatment. The CBT treatment program was developed based on the Matrix Model that considers cultural and social factors in the Philippines. After 6 months of treatment, there will be a three-month follow-up, when the participants' drug use (tested through urine testing) and other psychological variables, including craving, coping skills, and well-being, will be compared. Potential participants are given a summary of the study and a consent form. The consent form is signed and dated by participants prior to their study participation. Ethical approval was obtained prior to the commencement of the study.
This is the first randomized controlled trial to compare the residential CBT program and the TC model for methamphetamine users in the Philippines. The study aims to fill the current knowledge and capacity gaps by introducing a CBT-based treatment program to improve the psychosocial well-being of drug users in the Philippines. Moreover, if the effectiveness of the treatment program is demonstrated, anti-drug campaigns and severe sanctions against drug users may be reconsidered.
UMIN Clinical Trials Registry JPRN-UMIN000038597 . Registered on 15 November 2019. Protocol version October 17, 2021 ver.2.
菲律宾深受冰毒危机的影响。政府发起了一场打击毒品使用的政策战争，尽管对吸毒者实施的严厉制裁在国际上受到了批评。为了帮助实施更有效和人道的吸毒方法，本研究旨在引入一个基于认知行为疗法（CBT）的综合美沙酮使用者治疗计划，通过随机对照试验评估其有效性。
政府运营的康复设施中招募美沙酮使用者，并将他们随机分配到基于 CBT 的治疗计划或现有的治疗社区（TC）治疗中。CBT 治疗计划是基于 Matrix 模型开发的，该模型考虑了菲律宾的文化和社会因素。经过 6 个月的治疗后，将进行为期 3 个月的随访，届时将比较参与者的药物使用情况（通过尿液检测）和其他心理变量，包括渴望、应对技巧和幸福感。潜在参与者会收到研究摘要和同意书。参与者在参与研究之前签署并注明日期。在研究开始之前，已获得伦理批准。
这是第一项比较菲律宾美沙酮使用者住院 CBT 计划和 TC 模型的随机对照试验。该研究旨在通过引入基于 CBT 的治疗计划来填补当前的知识和能力差距，以改善菲律宾吸毒者的社会心理幸福感。此外，如果治疗计划的有效性得到证明，可能会重新考虑反毒品运动和对吸毒者的严厉制裁。
UMIN 临床研究注册 JPRN-UMIN000038597。于 2019 年 11 月 15 日注册。2021 年 10 月 17 日修订版第 2 版。
