An Open Label Trial of Lithium for the Management of Cannabis Withdrawal
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Depression
研究概览
简要总结
This trial will examine the efficacy of lithium in providing symptomatic relief from the withdrawal discomfort experienced by some dependent users of cannabis on cessation of regular use. Significant withdrawal may be a barrier to achieving abstinence in some clients and can be associated with marked disturbances in mood, sleep, hostility and aggression. Relief from such symptoms may be important in helping some clients achieve a period of abstinence and facilitate subsequent entry into a relapse prevention program.
详细描述
There are currently no accepted pharmacotherapies for the management of cannabis withdrawal. A recent study by Cui et al (2001) investigated the effects and mechanism of lithium on cannabinoid withdrawal in rats. The researchers found that lithium administration prevented the development of withdrawal symptoms, and suggested that increased oxytocin secretion resulting from lithium dosing prevented the withdrawal syndrome from occurring. Although caution should be exercised in generalising the results of an animal study, preliminary results of a small pilot study in humans are consistent with the potential utility of lithium in the management of human cannabis withdrawal (Zhang, personal communication). Furthermore, human use of lithium is well established and the addition of a readily available drug such as lithium carbonate would be a useful clinical tool should it prove efficacious in a series of clinical trials.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •DSM-IV diagnosis of cannabis dependence with at least a three-month history.
- •Seeking treatment for primary cannabis problem
- •Withdrawal identified as barrier to abstinence
排除标准
- •Other drug dependency (excluding nicotine)
- •Client is breastfeeding or pregnant.
- •Client has contraindicated medical or psychiatric conditions.
- •Client currently taking other medications that may interact with lithium.
- •Known hypersensitivity / side effects with Lithium.
- •Currently receiving Lithium from another source.
- •Currently prescribed any antidepressant / mood stabilising / antipsychotic medication.
- •Currently receiving opioid pharmacotherapy.
结局指标
主要结局
Depression
Anxiety
Aggression/Anger
Sleep difficulty
Severity of reported cannabis withdrawal symptoms
Treatment retention
Cannabis use
次要结局
未报告次要终点