Efficacy of Clonidine in Reducing Craving in Inpatients With Cocaine and Crack Use Disorder: a Randomized Clinical Trial.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
This is a single-center, randomized intervention study in a volunteer population of patients with cocaine/crack use disorder to evaluate the pharmacological treatment of cocaine/crack craving, comparing the drug clonidine with the active placebo clonazepam.
详细描述
Patients included will be administered clonidine 0.1 mg every 12 hours or clonazepam 0.25 mg every 12 hours for the first 2 weeks of treatment, followed by a washout for the final 2 weeks. The medication will be administered under the supervision of a member of the nursing staff. Patients will be monitored with vital signs three times a day to track changes that may be caused by the medication, such as reduced heart rate and hypotension. The primary outcome measure will be the change in cocaine craving at admission and two weeks after the start of treatment, using the visual analog scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients hospitalized in the adult Alcohol and Drugs ward of the Perdizes Institute (IPer) at the Hospital das Clínicas, University of São Paulo Medical School
- •DSM-5 criteria for cocaine and/or crack use disorder
- •Voluntarily seeking treatment
- •Must be able to swallow pills
排除标准
- •Inability to read and/or understand the study questionnaires
- •benzodiazepine use disorder
- •opioid use disorder
- •alcohol use disorder
研究组 & 干预措施
Control
Clonazepam 0,25 mg
干预措施: clonazepam 0,25 mg (Drug)
Intervention
Clonidine 0,1 mg
干预措施: clonidine (Drug)
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: Daily from enrollment to end of treatment at 2 weeks; then after 30, 60 and 90 days after end of treatment
Visual Analog Scale for craving, ranging from 0 to 10, where 0 means no craving and 10 means maximum craving
次要结局
- Adverse Effects(from the beginning of the intervention to 90 days after enrollment in the study)
- Blood pressure(Three times daily from baseline up to 14 days)
- Heart Rate(Three times daily from baseline up to 14 days)
- Cinical Global Impression - Severity of Illness (CGI-S)(At baseline)
- Clinical Global Impression - Improvement (CGI-I)(Will be assessed after 1 and 2 weeks from baseline)
- Crack/Cocaine Use(30, 60 and 90 days after the end of the intervention)
研究者
Dângela Layne Silva Lassi
Coordinator
University of Sao Paulo General Hospital