Using Cannabis to Treat Restless Legs Syndrome: A Randomized Placebo Controlled Pilot Safety and Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Incidence of Adverse Events and Serious Adverse Events
研究概览
简要总结
Restless Legs Syndrome (RLS) is a disorder that causes painful and uncomfortable sensations in the legs, and its symptoms have a significant impact on sleep and quality of life. Cannabis has been used by some RLS patients as a treatment due to its painkilling and drowsiness effects, however there has never been a clinical research trial investigating cannabis in patients with RLS. A controlled trial is needed to establish how safe and feasible cannabis is as a treatment for RLS. The investigators plan to randomize 30 participants with moderate-to-severe RLS to receive either cannabis or placebo for 8 weeks. The investigators will measure patients sleep quality and quality of life at baseline and 8-week follow-up. The investigators will also monitor patients for any adverse reactions to the study drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥25 years of age
- •diagnosis of RLS based on the International RLS Study Group criteria
- •refractory RLS symptoms despite use of dopaminergic and/or alpha-2-delta ligand therapy
- •onset of RLS at least 6 months before screening
排除标准
- •sleep disordered breathing, or sleep disordered breathing that is not adequately controlled on therapy (apnea-hypopnea index of >15)
- •cannabis use within 4 weeks of study enrollment
- •known allergy to cannabis, cannabinoids or palm/coconut oil
- •Currently pregnant or breast-feeding (a negative urine pregnancy test must be obtained for women of childbearing potential during pretreatment evaluation)
- •Active substance abuse
- •Ischemic heart disease with unstable angina or recent acute coronary syndrome in the last 3 months, uncontrolled arrhythmias, poorly controlled hypertension
- •Serious liver disease
- •History of schizophrenia or any other psychotic disorder
研究组 & 干预措施
Placebo Arm
Oral placebo
干预措施: Cannabis placebo (Drug)
Cannabis Arm
5:1 CBD:THC oral cannabis
干预措施: Cannabis oil (Drug)
结局指标
主要结局
Incidence of Adverse Events and Serious Adverse Events
时间窗: 8 weeks
We will measure the rate and type of treatment related adverse events
Rate of Study Completion
时间窗: 8 weeks
The percentage of enrolled participants who complete the study
次要结局
- Change from Baseline in Restless Legs Syndrome Quality of Life (RLSQoL) at 8 Weeks(8 weeks)
- Change in Restless Legs Syndrome Severity using the International RLS Study Group Rating Scale from Baseline to Follow-up(8 weeks)
- Change in Daytime Sleepiness as assessed by the Epworth Sleepiness Scale from Baseline to Follow-Up(8 weeks)
- Change from Baseline in Self-Reported Quality of Life on the Short Form-36 (SF-36) Health Survey Questionnaire at 8 Weeks(8 weeks)
- Change in Sleep Quality as assessed by the Pittsburgh Sleep Quality Index from Baseline to Follow-Up(8 weeks)
- Change in Mood as assessed by the Beck Depression Inventory from Baseline to Follow-Up(8 weeks)
- Change in Objective Sleep Quality as Measured by Actigraphy from Baseline to Follow-Up(8 weeks)
- Change in Leg Movements as Measured by Ankle Actigraphy from Baseline to Follow-Up(8 weeks)
- Change in Obstructive Sleep Apnea (OSA) Severity (as measured by the apnea-hypopnea index) from Baseline to Follow-Up(8 weeks)