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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
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Addiction focused on measuring mindfulness, cannabis use

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    November 23, 2017
    Last Updated
    April 18, 2018
    Sponsor
    Central Hospital, Nancy, France
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    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

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