Mindfulness Meditation and Cannabis Dependence : Therapy Effectiveness (MACBETH)

April 18, 2018 updated by: Central Hospital, Nancy, France

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline, weeks 7 and 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
at week 10
Patient retention rate at the end of treatment
Time Frame: at week 8
number of patients who continue study until week 8
at week 8
Severity of withdrawal symptoms questionnaire
Time Frame: At week 2, 4, 6, 8, 10, 12
measured by the Cannabis Withdrawal Scale (CWS)
At week 2, 4, 6, 8, 10, 12
ERG : electroretinogram.
Time Frame: week 0, 8, 12
measures a and b on ERG flash Measures P50 and N95 on ERG pattern
week 0, 8, 12
Thickness of retinal structure
Time Frame: at week 0 and 12
measured by Optical Coherence Tomography (OCT)
at week 0 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Vincent Laprevote, Centre Psychothérapique de Nancy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2018

Primary Completion (Anticipated)

August 30, 2019

Study Completion (Anticipated)

February 27, 2020

Study Registration Dates

First Submitted

November 23, 2017

First Submitted That Met QC Criteria

December 7, 2017

First Posted (Actual)

December 8, 2017

Study Record Updates

Last Update Posted (Actual)

April 19, 2018

Last Update Submitted That Met QC Criteria

April 18, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-A01466-47

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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