Trials · 2022
Electro-acupuncture for protracted amphetamine abstinence syndrome: study protocol for a pragmatic randomized controlled trial.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод в очереди
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Ren Huan, Zeng Yiwei, Zhang Min, Zhang Su, Chen Zhihan, Wu Binbin, Liu Jun, Ren Yulan
Аннотация
BACKGROUND: Protracted amphetamine abstinence syndrome is one of the primary causes of relapse for amphetamine-type drug abusers during withdrawal. However, the importance of the management of protracted amphetamine abstinence syndrome is underestimated. Electro-acupuncture may be a safe and effective alternative therapy for protracted amphetamine abstinence syndrome, but the evidence is limited.
METHODS: The study is a prospective, two-center, randomized, waitlist controlled, open-label pragmatic trial. A total of 300 patients with protracted amphetamine abstinence syndrome will be recruited. All participants will be randomly assigned to an electro-acupuncture group or a waitlist group in a 1:1 ratio. Participants in the electro-acupuncture group will receive the electrical-acupuncture treatment. Waitlist group participants will not receive electro-acupuncture treatment but will be assessed at each visit. Treatments will be administered twice a week for a total of 4 consecutive weeks. The primary outcome in this study is the change in the ACSA between baseline (week 0) and the completion of treatment (week 4), and the secondary outcomes are changes in the Hamilton Depression Scale (HAMD), the visual analog scale (VAS), the Hamilton Anxiety Scale (HAMA), the Pittsburgh Sleep Quality Index (PSQI), the Montreal Cognitive Assessment (MoCA), and the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36).
DISCUSSION: This study will assess the effectiveness of acupuncture in PAAS in real-world settings to provide support for clinical decisions and a basis for subsequent trials comparing acupuncture with other positive regimens.
TRIAL REGISTRATION: ClinicalTrials.gov ChiCTR2000040619 . Registered on 3 December 2020.
METHODS: The study is a prospective, two-center, randomized, waitlist controlled, open-label pragmatic trial. A total of 300 patients with protracted amphetamine abstinence syndrome will be recruited. All participants will be randomly assigned to an electro-acupuncture group or a waitlist group in a 1:1 ratio. Participants in the electro-acupuncture group will receive the electrical-acupuncture treatment. Waitlist group participants will not receive electro-acupuncture treatment but will be assessed at each visit. Treatments will be administered twice a week for a total of 4 consecutive weeks. The primary outcome in this study is the change in the ACSA between baseline (week 0) and the completion of treatment (week 4), and the secondary outcomes are changes in the Hamilton Depression Scale (HAMD), the visual analog scale (VAS), the Hamilton Anxiety Scale (HAMA), the Pittsburgh Sleep Quality Index (PSQI), the Montreal Cognitive Assessment (MoCA), and the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36).
DISCUSSION: This study will assess the effectiveness of acupuncture in PAAS in real-world settings to provide support for clinical decisions and a basis for subsequent trials comparing acupuncture with other positive regimens.
TRIAL REGISTRATION: ClinicalTrials.gov ChiCTR2000040619 . Registered on 3 December 2020.