Clinical trial NCT03366909: Mindfulness Meditation and Cannabis Dependence : Therapy Effectiveness
Official title: Mindfulness Meditation and Cannabis Dependence : Therapy Effectiveness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Addiction
Cannabis Use
Cannabis Dependence
Keywords: mindfulness
cannabis use
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2017-12-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in cannabis use between the baseline and the 8th week of treatment
timeFrame: At baseline, weeks 7 and 8
Secondary outcomes:
measure: Number of patients who stopped cannabis 2 weeks after 8 weeks of treatment
timeFrame: at week 10
measure: Patient retention rate at the end of treatment
timeFrame: at week 8
measure: Severity of withdrawal symptoms questionnaire
timeFrame: At week 2, 4, 6, 8, 10, 12
measure: ERG : electroretinogram.
timeFrame: week 0, 8, 12
measure: Thickness of retinal structure
timeFrame: at week 0 and 12
Other outcomes:
Locations:
Study officials:
affiliation: Centre Psychothérapique de Nancy
name: Vincent Laprevote
role: PRINCIPAL_INVESTIGATOR
References: