Double Blind, Placebo-Controlled Trial of THC as add-on Therapy for PTSD
试验速览
- 阶段
- 4 期
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Clinician Administered PTSD Scale
研究概览
简要总结
Stress Disorder (PTSD) is a chronic and debilitating anxiety disorder which is widespread in every social level and is very prevalent in outpatient and inpatient settings.
A recent open-label study showed that the synthetic cannabinoid receptor agonist Nabilone had beneficial effects abolishing or greatly reducing nightmares that persisted in spite of treatment with conventional PTSD medications. Furthermore, a big number of patients suffering from chronic PTSD report using smoked marijuana because its tranquilizing effect and sleep quality improvement. According to clinical and epidemiological data different derivates from the cannabis plant are illegally and pervasively consumed by PTSD patients in order to reduce distress.
The aim of the proposed study is to broaden the previous observations and to measure the extent to which Δ 9-THC will bring to significant improvement on the full spectrum of PTSD symptoms.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients between the 19-60 years of age with a diagnosis of PTSD.
- •Women must not be currently pregnant and must use a reliable method of contraception for the duration of the study.
- •Subjects must be on stable medication (4 weeks minimum) for their PTSD (symptomatic despite current treatment), must be able to provide written informed consent, must be able adequately understand and comply with the study's instructions and protocol .
排除标准
- •Those not meeting the inclusion criteria and those not able to give informed consent.
- •Women who are currently pregnant or nursing.
- •Those at immediate risk of harming self or others; those who have a clinically significant medical illness or other significant psychiatric illness;
- •currently abusing alcohol or drugs;
- •currently being treated with an investigational medication or medication that is contraindicated with cannabinoids;
- •have a known allergy to cannabis-based products.
研究组 & 干预措施
Placebo
Subjects will take 6 drops of olive oil orally twice a day from an identical vial than those in the active arm
干预措施: Placebo (Other)
ACTIVE THC
Subjects will take 5MG of THC in 6 drops of olive oil orally.
干预措施: Tetrahydrocannabinol (Drug)
结局指标
主要结局
Clinician Administered PTSD Scale
时间窗: Baseline and end o ftreatment
次要结局
- Nightmare Frequency Questionaire Score(Baseline Weeks 3 &6 (EOS))