Mindfulness Meditation and Cannabis Dependence : Therapy Effectiveness

Addiction Clinical Trial

— MACBETH  

Official title:

Mindfulness Meditation and Cannabis Dependence : Therapy Effectiveness

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03366909
• Other study ID #: 2017-A01466-47
• Status: Not yet recruiting
• Phase: N/A
• First received: November 23, 2017
• Last updated: April 18, 2018
• Start date: May 1, 2018
• Est. completion date: February 27, 2020

Study information

• Verified date: April 2018
• Source: Central Hospital, Nancy, France
• Contact: Vincent Laprevote
• Phone: 03 83 92 84 40
• Email: Vincent.LAPREVOTE[@]cpn-laxou.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: February 27, 2020
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Addiction
• Cannabis Dependence
• Cannabis Use
• Marijuana Abuse

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At baseline, weeks 7 and 8
Secondary	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)	at week 10
Secondary	Patient retention rate at the end of treatment	number of patients who continue study until week 8	at week 8
Secondary	Severity of withdrawal symptoms questionnaire	measured by the Cannabis Withdrawal Scale (CWS)	At week 2, 4, 6, 8, 10, 12
Secondary	ERG : electroretinogram.	measures a and b on ERG flash Measures P50 and N95 on ERG pattern	week 0, 8, 12
Secondary	Thickness of retinal structure	measured by Optical Coherence Tomography (OCT)	at week 0 and 12