Cannabinoids as a New Intervention for Amphetamine Dependence: A Proof-of-concept Study
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- assessing amphetamine craving
研究概览
简要总结
Addiction to amphetamine is characterized by alternating phases of intoxication and short abstinence, followed by recurrent drug-craving episodes which result in distress and relapse. Addiction involves a number of neurotransmission systems, including the endocannabinoid system (ECBS). It has been demonstarted that cannabidioids can have physiological, anxiolytic and neuroprotective properties. It has been shown to have multiple therapeutic properties for treating anxiety, schizophrenia and interestingly cannabinoids have been shown to be potentially helpful in treating addiction, due to their effects on various neuronal circuits involved in this disorder.
The investigators overall hypothesis is that cannabinoids are an interesting pharmacological contender to decrease amphetamine craving and treat amphetamine addiction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current DSM-V criteria for amphetamine use disorder
- •Ability to give valid, informed consent
排除标准
- •Severe and/or unstable hepatic, neurologic (including diagnosis of seizures), cardiac (including arrhythmias) or renal disease, or any other severe or unstable medical condition that precludes safe participation in the study according to the study physician.
- •Severe psychiatric condition (history of schizophrenia, schizoaffective disorder or bipolar disorder; current acute psychosis, mania or severe suicidality
- •Any serious medical condition or psychiatric illness that precludes the subject from signing the informed consent form
研究组 & 干预措施
placebo
干预措施: drug administration (Drug)
cannabinoid dose 1
干预措施: drug administration (Drug)
cannabinoid dose 2
干预措施: drug administration (Drug)
结局指标
主要结局
assessing amphetamine craving
时间窗: everyday during the study (that will last 3 days for each participants)
using questionnaire to assess craving and taking vital signs
次要结局
未报告次要终点