Mindfulness Meditation and Cannabis Dependence : Therapy Effectiveness (MACBETH)
Primary Purpose
Addiction, Cannabis Use, Cannabis Dependence
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mindfulness based relapse prevention (MBRP)
classic therapy
Sponsored by
About this trial
This is an interventional treatment trial for Addiction focused on measuring mindfulness, cannabis use
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MBRP group
classic care in addictology center
Arm Description
20 patients 2 groups of 10 patients
20 patients
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of patients who stopped cannabis 2 weeks after 8 weeks of treatment
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
number of patients who continue study until week 8
Severity of withdrawal symptoms questionnaire
measured by the Cannabis Withdrawal Scale (CWS)
ERG : electroretinogram.
measures a and b on ERG flash Measures P50 and N95 on ERG pattern
Thickness of retinal structure
measured by Optical Coherence Tomography (OCT)
Full Information
NCT ID
NCT03366909
First Posted
November 23, 2017
Last Updated
April 18, 2018
Sponsor
Central Hospital, Nancy, France
1. Study Identification
Unique Protocol Identification Number
NCT03366909
Brief Title
Mindfulness Meditation and Cannabis Dependence : Therapy Effectiveness
Acronym
MACBETH
Official Title
Mindfulness Meditation and Cannabis Dependence : Therapy Effectiveness
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2018 (Anticipated)
Primary Completion Date
August 30, 2019 (Anticipated)
Study Completion Date
February 27, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Addiction, Cannabis Use, Cannabis Dependence
Keywords
mindfulness, cannabis use
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MBRP group
Arm Type
Experimental
Arm Description
20 patients 2 groups of 10 patients
Arm Title
classic care in addictology center
Arm Type
Active Comparator
Arm Description
20 patients
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness based relapse prevention (MBRP)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
classic therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in cannabis use between the baseline and the 8th week of treatment
Description
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.
Time Frame
At baseline, weeks 7 and 8
Secondary Outcome Measure Information:
Title
Number of patients who stopped cannabis 2 weeks after 8 weeks of treatment
Description
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)
Time Frame
at week 10
Title
Patient retention rate at the end of treatment
Description
number of patients who continue study until week 8
Time Frame
at week 8
Title
Severity of withdrawal symptoms questionnaire
Description
measured by the Cannabis Withdrawal Scale (CWS)
Time Frame
At week 2, 4, 6, 8, 10, 12
Title
ERG : electroretinogram.
Description
measures a and b on ERG flash Measures P50 and N95 on ERG pattern
Time Frame
week 0, 8, 12
Title
Thickness of retinal structure
Description
measured by Optical Coherence Tomography (OCT)
Time Frame
at week 0 and 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vincent Laprevote
Phone
03 83 92 84 40
Email
Vincent.LAPREVOTE@cpn-laxou.com
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Schwitzer
Phone
03 83 92 84 40
Email
thomas.schwitzer@univ-lorraine.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Laprevote
Organizational Affiliation
Centre Psychothérapique de Nancy
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mindfulness Meditation and Cannabis Dependence : Therapy Effectiveness
We'll reach out to this number within 24 hrs