AddictionMACBETHNCT03366909
Mindfulness Meditation and Cannabis Dependence : Therapy Effectiveness
A study testing Mindfulness based relapse prevention (MBRP) and classic therapy in people with Addiction and Cannabis Use, run by Central Hospital, Nancy, France.
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Addiction, Cannabis Use, Cannabis Dependence
- What is being tested?
- Mindfulness based relapse prevention (MBRP) and classic therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2018to 27 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read more
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.
- Conditions
- Addiction, Cannabis Use, Cannabis Dependence
- Being tested
- Mindfulness based relapse prevention (MBRP), classic therapy
- Keywords
- mindfulness, cannabis use
- Medical subject headings
- Behavior, Addictive, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness based relapse prevention (MBRP)Behavioural
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 therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MBRP group | Experimental | 20 patients 2 groups of 10 patients Receives: Behavioral: Mindfulness based relapse prevention (MBRP) |
| classic care in addictology center | Active comparator | 20 patients Receives: Behavioral: classic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline, weeks 7 and 8
Secondary outcomes (5)
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)
Measured: at week 10
Patient retention rate at the end of treatment
number of patients who continue study until week 8
Measured: at week 8
Severity of withdrawal symptoms questionnaire
measured by the Cannabis Withdrawal Scale (CWS)
Measured: At week 2, 4, 6, 8, 10, 12
ERG : electroretinogram.
measures a and b on ERG flash Measures P50 and N95 on ERG pattern
Measured: week 0, 8, 12
Thickness of retinal structure
measured by Optical Coherence Tomography (OCT)
Measured: at week 0 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start1 May 2018 (estimated)
- Primary completion30 Aug 2019 (estimated)
- Study completion27 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AddictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Laprevote, Principal investigator, Centre Psychothérapique de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03366909
- Sponsor's protocol ID
- 2017-A01466-47
- Acronym
- MACBETH
- Status last verified
- Apr 2018
- First submitted
- 23 Nov 2017
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Meditation and Cannabis Dependence : Therapy Effectiveness
- ClinicalTrials.gov ID
- NCT03366909
- Acronym / sponsor ID
- MACBETH / 2017-A01466-47
- Conditions
- Addiction, Cannabis Use, Cannabis Dependence
- Keywords
- mindfulness, cannabis use
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 May 2018 (estimated)
- Primary completion
- 30 Aug 2019 (estimated)
- Study completion
- 27 Feb 2020 (estimated)
- First posted
- 8 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBRP group | Experimental | Behavioral: Mindfulness based relapse prevention (MBRP)20 patients 2 groups of 10 patients |
| classic care in addictology center | Active comparator | Behavioral: classic therapy20 patients |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | MBRP group |
| classic therapyThese 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. | Behavioural | classic care in addictology center |
Primary outcome
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.
5 secondary outcomes
Number of patients who stopped cannabis 2 weeks after 8 weeks of treatment
Time frame: at week 10
Patient retention rate at the end of treatment
Time frame: at week 8
Severity of withdrawal symptoms questionnaire
Time frame: At week 2, 4, 6, 8, 10, 12
ERG : electroretinogram.
Time frame: week 0, 8, 12
Thickness of retinal structure
Time frame: at week 0 and 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
- Individual participant dataSharing planned: No
Related trials for Addiction
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Recruiting
Tdcs And cogNitive traininG cOmbined for AUD (TANGO)
Alcohol Use Disorder, Addiction
Recruiting
Trial of Social Work Services in Fracture Clinic Setting
Orthopaedic Fractures, Socioeconomic Factors
RecruitingPhase 1
Open-Label Psilocybin Study in Transdiagnostic Population
Transdiagnostic, Depression - Major Depressive Disorder
Not yet recruiting
Interpersonal Relational Role Analysis Group Therapy for Nursing Students at Risk of Internet Addiction
Internet Addiction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Laprevote principal investigator
Centre Psychothérapique de Nancy
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness based relapse prevention (MBRP) and classic therapy in people with Addiction and Cannabis Use, run by Central Hospital, Nancy, France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincent Laprevote (03 83 92 84 40, Vincent.LAPREVOTE@cpn-laxou.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cannabis use between the baseline and the 8th week of treatment (time frame: At baseline, weeks 7 and 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2018.