Mindfulness Meditation and Cannabis Dependence : Therapy Effectiveness (MACBETH)
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|ClinicalTrials.gov Identifier: NCT03366909|
Recruitment Status : Not yet recruiting
First Posted : December 8, 2017
Last Update Posted : April 19, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Addiction Cannabis Use Cannabis Dependence||Behavioral: Mindfulness based relapse prevention (MBRP) Behavioral: classic therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mindfulness Meditation and Cannabis Dependence : Therapy Effectiveness|
|Estimated Study Start Date :||May 1, 2018|
|Estimated Primary Completion Date :||August 30, 2019|
|Estimated Study Completion Date :||February 27, 2020|
Experimental: MBRP group
20 patients 2 groups of 10 patients
Behavioral: Mindfulness based relapse prevention (MBRP)
These weekly visits include a Mindfulness Meditation session:
The sessions of meditation take place in a dedicated room. The collective sessions owed approximately of 2 hours and will approach the following themes: (1) Autopilot, (2) Facing obstacles, (3) Full awareness of breath, (4) Staying present, (5) Allow, let go (6) Thoughts are not facts, (7) How to take care of oneself, (8) Mindfulness on a daily basis.
Active Comparator: classic care in addictology center
Behavioral: classic therapy
These weekly visits include usual addiction care provided during a consultation. This care includes psychotherapeutic management: brief interventions, cognitive-behavioral therapies, motivational interviews; associated with nonsystematic pharmacological management.
- Change in cannabis use between the baseline and the 8th week of treatment [ Time Frame: 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.
- Number of patients who stopped cannabis 2 weeks after 8 weeks of treatment [ Time Frame: 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 [ Time Frame: at week 8 ]number of patients who continue study until week 8
- Severity of withdrawal symptoms questionnaire [ Time Frame: At week 2, 4, 6, 8, 10, 12 ]measured by the Cannabis Withdrawal Scale (CWS)
- ERG : electroretinogram. [ Time Frame: week 0, 8, 12 ]measures a and b on ERG flash Measures P50 and N95 on ERG pattern
- Thickness of retinal structure [ Time Frame: at week 0 and 12 ]measured by Optical Coherence Tomography (OCT)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03366909
|Contact: Vincent Laprevote||03 83 92 84 40||Vincent.LAPREVOTE@cpn-laxou.com|
|Contact: Thomas Schwitzer||03 83 92 84 firstname.lastname@example.org|
|Principal Investigator:||Vincent Laprevote||Centre Psychothérapique de Nancy|