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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
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Addiction Cannabis Use Cannabis Dependence Behavioral: Mindfulness based relapse prevention (MBRP) Behavioral: classic therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
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
20 patients
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. Patient retention rate at the end of treatment [ Time Frame: at week 8 ]
    number of patients who continue study until week 8

  3. Severity of withdrawal symptoms questionnaire [ Time Frame: At week 2, 4, 6, 8, 10, 12 ]
    measured by the Cannabis Withdrawal Scale (CWS)

  4. ERG : electroretinogram. [ Time Frame: week 0, 8, 12 ]
    measures a and b on ERG flash Measures P50 and N95 on ERG pattern

  5. Thickness of retinal structure [ Time Frame: at week 0 and 12 ]
    measured by Optical Coherence Tomography (OCT)



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Vincent Laprevote 03 83 92 84 40 Vincent.LAPREVOTE@cpn-laxou.com
Contact: Thomas Schwitzer 03 83 92 84 40 thomas.schwitzer@univ-lorraine.fr

Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Vincent Laprevote Centre Psychothérapique de Nancy

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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03366909     History of Changes
Other Study ID Numbers: 2017-A01466-47
First Posted: December 8, 2017    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Central Hospital, Nancy, France:
mindfulness
cannabis use
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders