EUCTR2013-004024-11-NL进行中（未招募）不适用
ew pharmacotherapeutic treatment options for crack-cocaine dependent people in the Netherlands: A double-blind, placebo-controlled randomized feasibility study of sustained release dexamphetamine
Academic Psychiatric Center - AMC-UvA0 个研究点开始时间: 2014年1月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •To qualify for heroin-assisted treatment, patients must meet a set of well-defined selection criteria pertaining to the situation prior to the start of heroin-assisted treatment, which include that the patient must be at least 25 years old, and have a treatment-resistant heroin dependency, as indicated by (a) a history of heroin dependence (DSM-IV) of at least five years, (b) a minimum dose of 50 mg/day (patients who inhale their heroin) or 60 mg/day (patients who inject their heroin) of methadone for an uninterrupted period of at least 4 weeks in the previous 5 years, (c) a history of regular treatment contacts with the methadone program in the previous 6 months, (d) a history of unsuccessful methadone maintenance treatments, (e) daily or nearly daily use of illicit heroin, and (f) poor physical, mental or social functioning (Van den Brink et al., 2003). It is important to note that these selection criteria for participation in heroin-assisted treatment pertain to the situation prior to the start of heroin-assisted treatment, which for most patients is (far) more than a year ago.
- •To be eligible for the present study, patients must:
- •1.be at least 25 years old;
- •2.be cocaine dependent (DSM-IV) during at least the previous 5 years;
- •3.use cocaine on a regular basis (i.e., = 8 days) in the previous month;
- •4.administer their cocaine primarily by means of basing ('crack');
- •5.have a history of earlier failed treatments aimed at reducing, or abstaining from, cocaine use ('treatment-refractory'). In order to qualify as 'treatment-refractory', the patient must have had at least two earlier treatment episodes targeted at reduction of cocaine use, yet still be cocaine dependent in the previous year, and use cocaine on a regular basis in the previous month;
- •6.be able and willing to participate in the study treatment and assessments;
- •7.have provided written informed consent.
- •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 72
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients will be excluded in case of:
- •1.severe medical (e.g., severe renal or kidney insufficiency/failure, hypertension, glaucoma) or psychiatric problems (e.g., acute psychosis or history of drug-induced psychotic disorder, acute suicidality), which constitute a contraindication for participation;
- •2.cardiovascular problems (ECG);
- •3.(desired) pregnancy or continued lactation;
- •4.anticipated necessity of inpatient treatment (clinical judgement);
- •5.insufficient command of the Dutch language;
- •6.current participation in another addiction treatment trial.
研究者
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