Mindfulness Meditation and Cannabis Dependence : Therapy Effectiveness
- Conditions
- Cannabis UseCannabis DependenceAddiction
- Interventions
- Behavioral: classic therapyBehavioral: Mindfulness based relapse prevention (MBRP)
- Registration Number
- NCT03366909
- Lead Sponsor
- Central Hospital, Nancy, France
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description classic care in addictology center classic therapy 20 patients MBRP group Mindfulness based relapse prevention (MBRP) 20 patients 2 groups of 10 patients
- Primary Outcome Measures
Name Time Method Change in cannabis use between the baseline and the 8th week of treatment 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.
- Secondary Outcome Measures
Name Time Method Severity of withdrawal symptoms questionnaire At week 2, 4, 6, 8, 10, 12 measured by the Cannabis Withdrawal Scale (CWS)
ERG : electroretinogram. week 0, 8, 12 measures a and b on ERG flash Measures P50 and N95 on ERG pattern
Number of patients who stopped cannabis 2 weeks after 8 weeks of treatment at week 10 measured by the absence of THC and metabolites in urinary and hair samples and the absence of cannabis use mentioned in the Timeline Follow Back retrospective diary (TLFB)
Patient retention rate at the end of treatment at week 8 number of patients who continue study until week 8
Thickness of retinal structure at week 0 and 12 measured by Optical Coherence Tomography (OCT)