Evaluation of the Effect of tDCS on Cannabis Craving (TCC)
Primary Purpose
Addiction to Cannabis
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Neuromodulation by tDCS
Sponsored by
About this trial
This is an interventional other trial for Addiction to Cannabis
Eligibility Criteria
Inclusion Criteria:
- Men or women between 18 and 65 years of age
- Right-Handers
- Diagnosis: Cannabis Use Disorder (according to DSM 5 criteria)
- Patient with no other drug or psychotherapeutic treatment for cannabis addiction ("naive" patients)
- Reported use of cannabis more than three times a week in the past three years
- Signing consent to participate in research
Exclusion Criteria:
- Pregnancy or lack of effective contraception
- Patients with severe somatic disease
- Other addictions of "moderate" to "severe" intensity according to DSM 5 criteria (excluding tobacco and coffee)
- Patients undergoing antidepressant or neuroleptic or thyroid-regulating therapy.
- Contraindications to tDCS (presence of an intracranial metal body, intracranial hypertension)
- Topic that has already been stimulated by tDCS
- Patients under reinforced guardianship or curatorship
Sites / Locations
- Youcef BENCHERIFRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
tDCS active arm
tDCS placebo
Arm Description
Outcomes
Primary Outcome Measures
Evaluating the change from craving to cannabis. by an analog visual scale .Scores (0 to 10)
Secondary Outcome Measures
The change to cannabis craving assessed by the Baseline Marijuana Craving Test at the end of treatment
The change in cannabis craving during an incentive to use task evaluated by analog visual scale scores (0 to 10)
Montgomery-Åsberg depression rating scale) Scores (0 to 60)
evaluation of the change in the number of joints consumed per day
evaluation of the change in the number of cigarettes consumed per day
assessment of the change in attention and inhibition skills as assessed by the Stroop test before and after a neurofeedback test
the Gambling Task's assessment of decreased risk-taking
Young Mania Rating Scale Scores (0 to 60)
Beck Depression Inventory Scores (0 to 39)
Clinical Global Impression Severity of disease (0 to 7)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04389528
Brief Title
Evaluation of the Effect of tDCS on Cannabis Craving
Acronym
TCC
Official Title
Evaluation of the Effect of tDCS on Cannabis Craving: Multicentre Randomized, Double-blind Study Versus Placebo
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 17, 2018 (Actual)
Primary Completion Date
July 17, 2021 (Anticipated)
Study Completion Date
December 17, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Januel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Cannabis is the most frequently consumed drug in France and its use continues to increase. Over the 18-64 age group as a whole, experimentation with cannabis at least once in a lifetime increased from 33% in 2010 to 42% in 2014, confirming the upward trend observed since the 1990.
Cannabis, like all drugs, disrupts the reward circuit whose neurons originate in the ventral tegmental area and project into the mesolimbic and cortical structures.
Acute cannabis use is thought to increase mesolimbic dopamine by affecting the Gabaergic or Glutamatergic system.
Chronic cannabis use usurps the reward system and leads to changes in the mesolimbic circuit (nucleus accumbens, ventral tegmental area, amygdala, and prefrontal cortex), inducing increased craving, with persistent craving for the substance and vulnerability to relapse.
Cognitively, addiction is associated with increased impulsivity, with a propensity to take risks leading to impaired decision-making.
There is currently no validated drug treatment for cannabis addiction. Non-invasive brain stimulation could be an interesting therapeutic alternative.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Addiction to Cannabis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
double-blind randomized study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
tDCS active arm
Arm Type
Experimental
Arm Title
tDCS placebo
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Neuromodulation by tDCS
Intervention Description
The tDCS is a device for modulating cortical excitability. It consists of passing a low intensity direct electrical current over the scalp via two electrodes: an anode and a cathode soaked in a saline solution. Although there is a short-circuit effect through the scalp, a significant amount of electrical current enters the brain and changes the transmembrane potential.
Primary Outcome Measure Information:
Title
Evaluating the change from craving to cannabis. by an analog visual scale .Scores (0 to 10)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
The change to cannabis craving assessed by the Baseline Marijuana Craving Test at the end of treatment
Time Frame
3 month
Title
The change in cannabis craving during an incentive to use task evaluated by analog visual scale scores (0 to 10)
Time Frame
3 months
Title
Montgomery-Åsberg depression rating scale) Scores (0 to 60)
Time Frame
3 months
Title
evaluation of the change in the number of joints consumed per day
Time Frame
3 months
Title
evaluation of the change in the number of cigarettes consumed per day
Time Frame
3 months
Title
assessment of the change in attention and inhibition skills as assessed by the Stroop test before and after a neurofeedback test
Time Frame
3 months
Title
the Gambling Task's assessment of decreased risk-taking
Time Frame
3 months
Title
Young Mania Rating Scale Scores (0 to 60)
Time Frame
3 months
Title
Beck Depression Inventory Scores (0 to 39)
Time Frame
3 months
Title
Clinical Global Impression Severity of disease (0 to 7)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
63 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Men or women between 18 and 65 years of age
Right-Handers
Diagnosis: Cannabis Use Disorder (according to DSM 5 criteria)
Patient with no other drug or psychotherapeutic treatment for cannabis addiction ("naive" patients)
Reported use of cannabis more than three times a week in the past three years
Signing consent to participate in research
Exclusion Criteria:
Pregnancy or lack of effective contraception
Patients with severe somatic disease
Other addictions of "moderate" to "severe" intensity according to DSM 5 criteria (excluding tobacco and coffee)
Patients undergoing antidepressant or neuroleptic or thyroid-regulating therapy.
Contraindications to tDCS (presence of an intracranial metal body, intracranial hypertension)
Topic that has already been stimulated by tDCS
Patients under reinforced guardianship or curatorship
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Youcef BENCHERIF
Phone
0143093232
Email
y.bencherif@epsve.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Rusheenthira THAVASEELAN
Phone
0143093232
Email
r.thavaseelan@epsve.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noomane BOUAZIZ
Organizational Affiliation
Clinical Unite research of EPS Ville Evrard
Official's Role
Principal Investigator
Facility Information:
Facility Name
Youcef BENCHERIF
City
Maisons Alfort
State/Province
Île De France
ZIP/Postal Code
94700
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Youcef BENCHERIF, CRA
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Effect of tDCS on Cannabis Craving
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