NCT00495183Unknown4 期
Efficacy of Caffeine, With and Without Biperiden, as a Maintenance Treatment for Cocaine Dependence
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- cocaine use
研究概览
简要总结
The aim of this study is to assess the efficacy of caffeine compared to placebo as a maintenance treatment for cocaine dependence. Caffeine potentiation with biperiden will be also studied.
Ninety patients with snorted/sniffed cocaine dependence will be randomized to receive caffeine (300 - 1200 mg t.i.d.) plus biperidene (8 mg b.i.d.) caffeine (300 - 1200 mg t.i.d.) with placebo or placebo during 10 days in an in-hospital setting.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of cocaine dependence, according to DSM-IV-TR criteria
- •age between 18 and 60 years
- •current cocaine use, confirmed by a positive urine drug screen for cocaine the week prior to admission.
- •demonstrated capacity to grant informed consent and sign the pertinent informed consent form.
- •place of residence compatible with attendance at the center.
- •for women, willingness to use effective contraceptive measures during the study.
排除标准
- •diagnosis of a severe medical disorder that could interfere with the study
- •presence of an organic pathology for which methylxanthines or biperidene administration is contraindicated
- •serum liver transaminase levels 3 times higher than normal values
- •pregnancy and breast-feeding
- •neuroleptic medication treatment in the past 6 weeks
- •current treatment, or anticipation that the patient may need to initiate treatment during the study, with drugs that may interact with study medication.
- •current diagnosis of a major mental disorder.
- •awareness of a situation that could prevent the patient's participation in the study (e.g. serving a sentence)
- •current participation in another research project.
研究组 & 干预措施
1
Experimental
caffeine + placebo
干预措施: caffeine (Drug)
2
Experimental
caffeine + biperiden
干预措施: caffeine (Drug)
2
Experimental
caffeine + biperiden
干预措施: Biperiden (Drug)
3
Placebo Comparator
Placebo+placebo
干预措施: Placebo (Drug)
结局指标
主要结局
cocaine use
时间窗: 22 weeks
survival
时间窗: 22 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Efficacy of Caffeine, With and Without Biperiden, in the Detoxification of Cocaine Dependent PatientsCocaine Related DisordersNCT00495092Hospital Universitari Vall d'Hebron Research Institute85
尚未招募
4 期
Can Caffeine prevent the cessation of breathing in preterm newborn babies?ACTRN12621001000897Mansoor Aslamzai130
招募中
1 期
The effect of two maintenance doses of caffeine citrate 5 and 10 on premature retinopathy in very low birth weight infantsRetinopathy.H35.1RetinopathyIRCT20210110049985N1Babol University of Medical Sciences100
尚未招募
4 期
Comparing The Prophylactic Effects of Caffeine versus Aminophylline on the Apnea of Prematurity in Neonates of Kabul City: A randomized clinical trialPrematurity and low birth weightP07Disorders related to short gestation and low birth weight, not elsewhere classifiedDRKS00020404Ministry of Higher Education, Research Committee80
招募中
2 期
The effect of caffeine on neurorehabilitation after strokeStroke.Sequelae of stroke, not specified as haemorrhage or infarctionIRCT2017021832625N1Vice-chancellor for Research of Shiraz University of Medical Sciences40