An interventional study of Mindfulness based relapse prevention (MBRP) and classic therapy in Addiction, Cannabis Use and Cannabis Dependence, sponsored by Central Hospital, Nancy, France. Status unknown. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2018-04-19.
Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Treatment
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.
521 studies on the registry are indexed under Behavior, Addictive; 124 are open to participants now.
This study's planned enrollment of 40 is below the median of 62 across 399 interventional studies indexed under Behavior, Addictive.
Browse Behavior, Addictive studies →Central Hospital, Nancy, France is the lead sponsor of 798 studies on the registry; 186 are open to participants now.
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Exclusion Criteria:
20 patients 2 groups of 10 patients
Behavioral: Mindfulness based relapse prevention (MBRP)
20 patients
Behavioral: classic therapy
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.
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.
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.
Time frame: At baseline, weeks 7 and 8
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)
Time frame: at week 10
Patient retention rate at the end of treatment
number of patients who continue study until week 8
Time frame: at week 8
Severity of withdrawal symptoms questionnaire
measured by the Cannabis Withdrawal Scale (CWS)
Time frame: At week 2, 4, 6, 8, 10, 12
ERG : electroretinogram.
measures a and b on ERG flash Measures P50 and N95 on ERG pattern
Time frame: week 0, 8, 12
Thickness of retinal structure
measured by Optical Coherence Tomography (OCT)
Time frame: at week 0 and 12
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for May 2018; primary completion for Aug 2019, 15 months later.
Of 147 non-industry interventional studies with no phase under Behavior, Addictive, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 42. This study's planned 15 months is below that.
Counting every sponsor, half of 155 studies reached it within 26 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Central Hospital, Nancy, France →