2023-505556-21-00招募中3 期
Efficacy and safety of 24 weeks sustained-release dexamphetamine in patients with moderate to severe cocaine use disorder with comorbid opioid use disorder - a multicenter randomized, double-blind, placebo-controlled study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 204
- 试验地点
- 3
- 主要终点
- The primary endpoint is defined as the number of days of cocaine abstinence in the final 4 weeks of treatment (i.e., weeks 21–24), assessed by combined self-report and urinalysis.
研究概览
简要总结
To evaluate the efficacy of 24 weeks SR-dexamphetamine (individually titrated to a maximum dosage of 90 mg/day, as tolerated), compared with 24 weeks placebo, in patients with moderate/severe cocaine use disorder, in routine opioid agonist treatment with oral methadone for their comorbid opioid dependence in terms of days of cocaine abstinence and overall health status.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •actively participating in opioid agonist treatment with oral methadone
- •with moderate or severe cocaine use disorder according to DSM-5
- •with regular use of cocaine in the previous month
- •with snorting, inhaling or injecting cocaine use as primary route of administration
- •express the intention to reduce or stop their cocaine use
- •be able and willing to attend the treatment center for 2 days per week
- •be able and willing to co-operate with the required study assessments and study procedures
- •have provided written informed consent
排除标准
- •severe medical (e.g., severe renal or hepatic insufficiency/failure) or severe psychiatric problems (e.g. severe previous or acute psychotic episode, acute suicidality, current bipolar disorder)
- •anticipated need for inpatient treatment (clinical judgement)
- •(expected) inability to complete the 30 weeks study (e.g., planned holidays, expected incarceration or hospitalization)
- •insufficient command of the Dutch language
- •current participation in another addiction treatment study
- •cardiovascular problems: clinically relevant ECG abnormalities suggestive of channelopathy or structural or ischemic heart disease; moderate to severe hypertension (i.e., SBP>140; DBP>90); HR>100, known coronary artery disease (i.e., angina pectoris, acute myocardial infarction), known cardiomyopathy, CVA
- •Gilles-de-la-Tourettesyndrome
- •pheochromocytoma
- •hyperthyroid status
- •pregnancy or continued lactation
- •use of monoamine oxidase inhibitor(s) (MAOI): currently or in the past 14 days
- •(indication for) treatment with other prescription psychostimulants that might potentially be effective for stimulant use disorder (i.e., (immediate release) dexamphetamine, lisdexamphetamine, methylphenidate, or modafinil)
结局指标
主要结局
The primary endpoint is defined as the number of days of cocaine abstinence in the final 4 weeks of treatment (i.e., weeks 21–24), assessed by combined self-report and urinalysis.
The primary endpoint is defined as the number of days of cocaine abstinence in the final 4 weeks of treatment (i.e., weeks 21–24), assessed by combined self-report and urinalysis.
The key secondary endpoint is defined as "good or improved overall health status", in terms of physical health, mental health, and social functioning
The key secondary endpoint is defined as "good or improved overall health status", in terms of physical health, mental health, and social functioning
次要结局
- The number and proportion of patients starting and completing 24 weeks treatment
- Maximum dose received; dose at the end of week 4; dose in final 4 weeks of study phase 1 (weeks 21–24); dose in final 4 weeks of study phase 2 (weeks 27–30)
- Safety will be assessed and reported in terms of: Vital signs (heart rate, blood pressure) and body weight; ECG and safety laboratory parameters (NT-proBNP, and hs-Troponine); Adverse events (AEs; solicited and unsolicited) and serious adverse events (SAEs)
- The number of days cocaine abstinence in the final 4 weeks of the discontinuation phase of the study (i.e., weeks 27–30)
- The overall health status of patients in the final 4 weeks of the discontinuation study phase 2 (weeks 27–30), - defined as "deteriorated overall health status", in terms of physical health, mental health, and social functioning -
- A dichotomous outcome of deterioration (yes versus no) based on the composite outcome of (1) a clinically relevant decrease of ≥5 days/month in cocaine abstinent days and/or (2) deterioration in overall health status.
- Total number of days cocaine abstinence during first 12 weeks treatment (i.e., 0–84 days)
- Total number of days cocaine abstinence during 24 weeks treatment (i.e., 0–168 days).
- Complete abstinence from cocaine during 24 weeks treatment.
- Achieving a period of sustained abstinence from cocaine for at least 21 consecutive days.
- At least 40% reduction in cocaine use (days/month) in the final 4 weeks of treatment (weeks 21–24), compared with baseline.
- Number of weeks of uninterrupted cocaine abstinence sustained till abstinence during final treatment week in study phase 1
- Average number of cocaine administrations on days that cocaine was used.
- Cocaine craving
研究者
Peter Blanken
Scientific
Parnassia Groep B.V.
研究点 (3)
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