Mindfulness Meditation and Cannabis Dependence : Therapy Effectiveness
MACBETH
1 other identifier
interventional
40
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2018
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2017
CompletedFirst Posted
Study publicly available on registry
December 8, 2017
CompletedStudy Start
First participant enrolled
May 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 27, 2020
CompletedApril 19, 2018
April 1, 2018
1.3 years
November 23, 2017
April 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in cannabis use between the baseline and the 8th week of treatment
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.
At baseline, weeks 7 and 8
Secondary Outcomes (5)
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
Severity of withdrawal symptoms questionnaire
At week 2, 4, 6, 8, 10, 12
ERG : electroretinogram.
week 0, 8, 12
Thickness of retinal structure
at week 0 and 12
Study Arms (2)
MBRP group
EXPERIMENTAL20 patients 2 groups of 10 patients
classic care in addictology center
ACTIVE COMPARATOR20 patients
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vincent Laprevote
Centre Psychothérapique de Nancy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2017
First Posted
December 8, 2017
Study Start
May 1, 2018
Primary Completion
August 30, 2019
Study Completion
February 27, 2020
Last Updated
April 19, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share