The Effect of Medical Cannabis on Tics, Premonitory Urge and Psychiatric Comorbidity in Adults With Tourette Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in vocal and motor tics and disease burden
研究概览
简要总结
Medical cannabis (MC) is a standard treatment in Israel to adults with resistant Gilles de la Tourette syndrome (GTS). While small randomized control trials assessed THC efficacy on tics and premonitory urge, only small retrospective studies assessed MC efficacy and tolerability in GTS. Herein, By using an open-label, prospective design, our aim is to determine the preferred method of use, efficacy and tolerability of 12 weeks of treatment with MC in adult patients with GTS.
详细描述
Gilles de la Tourette syndrome (GTS) is a childhood onset neuropsychiatric disorder characterized by the presence of multiple motor and one or more phonic tics continuing for at least one year. In Israel, although consumption of cannabis is outlawed, there is an option to allow patients to consume the drug under supervision. Medical Cannabis (MC) consumed by inhalation of smoked or vaporized dried female buds, or subligual oil extract of whole plant, has been an approved treatment by the Ministry of Health (MOH) for resistant GTS since 2013. Previous studies suggested that MC has a good effect on tics, quality of like and with good tolerability among patients with resistant GTS.
In the current study, we prospectively followed-up patients eligible for MC according to MOH restrictions, at our GTS clinic at the Tel-Aviv Sourasky Movement Disorders Unit (MDU). Each subject signed a written informed consent before inclusion in the trial. Also, since driving under the influence of cannabis is forbidden by the Israeli law, patients were instructed and gave their oral commitment to avoid driving. The study was approved by the research ethics (Helsinki) committee at our center. MC was consumed as oil extract, vaporized, or smoked dried buds. The treating neurologist (S.A.) and patient together decided on the method of consumption during the visit before initiating treatment. Patients were assessed 4 and 12-weeks following treatment initiation to gather data regarding treatment efficacy, tolerability and SEs.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Age 18 - 65 years
- •Diagnosis of GTS confirmed by the treating neurologist based on the DSM-V criteria
- •Eligibility to receive MOH MC license for GTS
- •Provided written informed consent
排除标准
- •Regularly use cannabis in any form for self-medication prior to entering the study
- •Pregnant or lactating women
- •Have a tic disorder other than GTS
- •Have concurrent physical or mental disease that could interfere with the study
研究组 & 干预措施
Adult Tourette syndrome patients
Patients will be assessed before (baseline), 4 (visit 2) and 12 weeks (visit 3) after use of Medical cannabis via inhaled dried buds or sublingual oil extract. The percentage of THC and CBD were pre-set to 10% and 2%, respectively. All patients received the same general instructions for treatment titration, which was to start with 1 drop or puff a day and increase by 1 drop or puff as needed. There was no fixed schedule for the incremental increases, thus each patient freely raised the dose as well as number of daily consumptions until clinical benefit was achieved or SE emerged over a follow-up period of 12 weeks.
干预措施: Medical Cannabis (Drug)
结局指标
主要结局
Change in vocal and motor tics and disease burden
时间窗: Baseline, after 4 and 12 weeks since treatment initiation
Using Yale Global Tic Severity Scale (YGTSS), range 0-100, higher scores mean a worse outcome
Change in premonitory urge
时间窗: Baseline, after 4 and 12 weeks since treatment initiation
using Premonitory Urge for Tic Scale (PUTS), range 0-36, higher scores mean a worse outcome
Subjective improvement of tics and Quality of life
时间窗: Baseline, after 4 and 12 weeks since treatment initiation
Using a 7-point Likert-type scale, range 1-7, higher scores mean a better outcome
次要结局
- Examine patient's tetrahydrocannabinol-9-delta (THC) and Cannabidiol (CBD) consumption per month(After 12 weeks since treatment initiation)
- Assessment of major side effects of treatment(After 4 and 12 weeks since treatment initiation)