Mindfulness Meditation and Cannabis Dependence : Therapy Effectiveness
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 主要终点
- Change in cannabis use between the baseline and the 8th week of treatment
研究概览
简要总结
Cannabis use can lead to addiction in about 5 to 10 % of users in France. Currently, behavioral interventions are the most dependable but effectiveness is still reduced. Mindfulness meditation has demonstrated an effectiveness in several meta analysis (anxiety and depressive disorder) and seems to be relevant to reduce anxious and impulsive symptoms found in cannabis use disorders.
This study proposes to determinate the mindfulness effectiveness in reduction of cannabis use in regular consumer. The consumption decrease is estimated with a retrospective diary, TLFB (Timeline Follow Back) which collect cannabis use every week until the 12th. Urine (week 0/baseline, 2, 4, 6, 8, 10, 12) and hair (week 0/baseline, 10) analyses are regularly effected.
Patients included in control group get classic cares in an addictology center in CHRU of Nancy. Patients included in mindfulness group receive one session a week during eight weeks (MBRP protocol : Mindfulness -Based Relapse Prevention). The study process goes on for 12 weeks.
An ancillary study measures the impact of cannabis decreases on retinal electrophysiological and architectural markers, usually disturbed by cannabis uses.
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
- 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
- 否
入选标准
- •Aged from 18 to 55
- •cannabis use: more than 7 joint a week or diagnostic of abuse/dependence at MINI (mini international neuropsychiatric interview)
- •Recent use authenticated in urine
- •patient voluntary to stop cannabis use
- •patient with social security
- •written consent for study
排除标准
- •alcohol dependence (AUDIT: alcohol use disorders test)
- •other psychoactive substance abuse or dependence (DSM 4)
- •Progressive psychiatric disorder (MINII) excepted anxious disorder)
- •Current neurologic disorder
- •Patient deficiency with difficulty or impossibility to understand informations
- •protection of vulnerable adults as guardianship or judicial protection
- •pregnant or breastfeeding woman
- •vital emergency
- •no social security
- •participation in another interventional study
- •current retinal disorder (ancillary study)
- •chronic glaucoma (ancillary study)
- •opthalmologic disease decreasing visual acuity (ancillary study)
- •current ocular infection
研究组 & 干预措施
MBRP group
20 patients 2 groups of 10 patients
干预措施: Mindfulness based relapse prevention (MBRP) (Behavioral)
classic care in addictology center
20 patients
干预措施: classic therapy (Behavioral)
结局指标
主要结局
Change in cannabis use between the baseline and the 8th week of treatment
时间窗: At baseline, weeks 7 and 8
The number of days of cannabis use (addition weeks 7 and 8) will be compared to the " less than or equal to 4 days"target.
次要结局
- Severity of withdrawal symptoms questionnaire(At week 2, 4, 6, 8, 10, 12)
- ERG : electroretinogram.(week 0, 8, 12)
- Number of patients who stopped cannabis 2 weeks after 8 weeks of treatment(at week 10)
- Patient retention rate at the end of treatment(at week 8)
- Thickness of retinal structure(at week 0 and 12)