Phase 1, Pilot Study to Examine the Cardiovascular Effects of Smoked Marijuana, Interactions With Oral Dronabinol, and Effects of Dronabinol on Withdrawal in Marijuana Dependent Volunteers

National Institute on Drug Abuse (NIDA)2 个研究点分布在 1 个国家目标入组 6 人开始时间: 2007年3月最近更新: 2017年1月16日

适应症

试验速览

阶段: 1 期
状态: 终止
发起方: National Institute on Drug Abuse (NIDA)
入组人数: 6
试验地点: 2
主要终点: Cardiovascular responses

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to examine the effects of oral dronabinol tetrahydrocannabinol (THC) on withdrawal symptoms in marijuana dependent volunteers, and evaluate the safety, pharmacokinetics (PK), and cardiovascular effects of the combination of oral dronabinol and smoked marijuana to determine if there are potential significant interactions before conducting outpatient studies.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 45 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Must be between the ages of 18 to 45 years of age
•Must be in good general health
•Must meet DSM-IV criteria for marijuana dependence and are non- treatment seekers at the time of study
•Must be able to provide written informed consent
•Must be able to provide 1 marijuana positive urine specimen (> 50 ng/mL) within the 28-day screening period
•If female and of child bearing potential, must agree to use birth control.
•Please contact site for more information.

排除标准

未提供

结局指标

主要结局

Cardiovascular responses

次要结局

未报告次要终点

研究者

发起方

National Institute on Drug Abuse (NIDA)

申办方类型

Nih

研究点 (2)

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