EUCTR2009-010584-16-NL进行中(未招募)不适用
ew pharmacotherapeutic treatment options for crack-cocaine dependent people in the Netherlands.
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- ZonMw
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •(a) at least 18 years old
- •(b) cocaine dependence (DSM-IV) during at least the previous year
- •(c) cocaine use on a regular basis (i.e., = 8 days) in the previous month
- •(d) administer cocaine primarily by means of basing ('crack')
- •(e) able and willing to participate in outpatient psycho-social treatment and associated assessments (control condition), or be able and willing to participate in outpatient psycho-social treatment supplemented with the study medication and associated assessments (experimental condition)
- •(f) have provided written informed consent with regard to their assigned study treatment
- •In the sub-study with dexamphetamine SR, the minimal duration of cocaine dependency will be five years instead of one year. In addition, patients have to meet one extra inclusion criterion: (g) a history of earlier failed treatments aimed at reducing, or abstaining from, cocaine use ('treatment-refractory').
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •(a) severe medical (e.g., severe renal or kidney insufficiency/failure) or psychiatric problems (e.g. acute psychosis, current major depression, suicidal) as well as comorbid heroin dependence, which constitute a contra-indication for participation
- •(b) cardiovascular problems (ECG)
- •(c) pregnancy or continued lactation
- •(d) indication for treatment with naltrexone, disulfiram, or acamprosate
- •(e) anticipated necessity of residential treatment (clinical judgement)
- •(f) insufficient command of the Dutch language
- •(g) current participation in another addiction treatment trial
研究者
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