ACTRN12617000657325已完成3 期
A randomised double blind placebo controlled study of lisdexamfetamine for the treatment of methamphetamine dependence
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 155
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1.Provide written, informed consent to participate in the study.
- •2.Aged 18 to 65 years
- •3.Be treatment seeking for methamphetamine use
- •4.Meet ICD-10 criteria for methamphetamine dependence for at least twelve months
- •5.Self-report methamphetamine use of at least 14 days out of the previous 28
- •6.Have one urine drug screen (UDS) positive for methamphetamine within 7 days prior to registration
- •7.Participants must have the ability to store study medication securely
- •8.Be willing and able to comply with requirements of study
排除标准
- •9.Current effective counselling based treatment for methamphetamine dependence
- •10.Current pharmacotherapy treatment for opioid dependence
- •11.Use of prescribed dexamphetamine or modafinil in the previous four weeks
- •12.Current dependent use of alcohol or non-prescribed substances other than amphetamines, diagnosed by specialist clinical assessment against ICD-10 criteria, which in the opinion of the investigator would interfere with participation in the study.
- •13.Currently lactating or pregnant, or of childbearing potential and not willing to avoid becoming pregnant during the study
- •14.Sensitivity or previous adverse reaction to lisdexamfetamine
- •15.Current, severe medical disorder (e.g. Cardiovascular disease, uncontrolled hypertension, peripheral vascular disease, assessed by study medical officer)
- •16.Current, severe psychiatric disorder (e.g. Acute psychosis, severe anxiety and/or mood disorder, intent to harm self or others assessed by study medical officer and/or psychiatrist)
- •17.History of glaucoma, hyperthyroidism, pheochromocytoma, motor tics, vocal tics or Tourette’s syndrome
- •18.Use of monoamine oxidase inhibitors in previous 14 days; or use of other medications that could interact with study medication on assessment by the investigator.
- •19.Exposure to any investigational drug within the 4 weeks prior to screening
- •Note: Co-enrolment in another study not involving an investigational drug is not an exclusion criterion, provided it does not cause undue burden on the participant or effect the ethical, safety, statistical, or practical requirements of this study as determined by the PI
- •20.Not available for follow-up (e.g. Likely travel or imprisonment)
- •21.Undergoing child protection service/court/work ordered drug testing
研究者
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