Mindfulness Meditation and Cannabis Dependence : Therapy Effectiveness

NCT ID: NCT03366909

Last Updated: 2018-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2020-02-27

Brief Summary

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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.

Detailed Description

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Conditions

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Addiction Cannabis Use Cannabis Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MBRP group

20 patients 2 groups of 10 patients

Group Type EXPERIMENTAL

Mindfulness based relapse prevention (MBRP)

Intervention Type BEHAVIORAL

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.

classic care in addictology center

20 patients

Group Type ACTIVE_COMPARATOR

classic therapy

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vincent Laprevote

Role: PRINCIPAL_INVESTIGATOR

Centre Psychothérapique de Nancy

Central Contacts

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Vincent Laprevote

Role: CONTACT

03 83 92 84 40

Thomas Schwitzer

Role: CONTACT

03 83 92 84 40

Other Identifiers

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2017-A01466-47

Identifier Type: -

Identifier Source: org_study_id

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