Clinical trial NCT04389528: Evaluation of the Effect of tDCS on Cannabis Craving
Official title: Evaluation of the Effect of tDCS on Cannabis Craving: Multicentre Randomized, Double-blind Study Versus Placebo
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Addiction to Cannabis
Lead sponsor: Centre hospitalier de Ville-Evrard, France
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 63
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double-blind randomized study
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

1. Men or women between 18 and 65 years of age
2. Right-Handers
3. Diagnosis: Cannabis Use Disorder (according to DSM 5 criteria)
4. Patient with no other drug or psychotherapeutic treatment for cannabis addiction ("naive" patients)
5. Reported use of cannabis more than three times a week in the past three years
6. Signing consent to participate in research

Exclusion Criteria:

1. Pregnancy or lack of effective contraception
2. Patients with severe somatic disease
3. Other addictions of "moderate" to "severe" intensity according to DSM 5 criteria (excluding tobacco and coffee)
4. Patients undergoing antidepressant or neuroleptic or thyroid-regulating therapy.
5. Contraindications to tDCS (presence of an intracranial metal body, intracranial hypertension)
6. Topic that has already been stimulated by tDCS
7. Patients under reinforced guardianship or curatorship

Primary outcomes:
measure: Evaluating the change from craving to cannabis. by an analog visual scale .Scores (0 to 10)
timeFrame: 3 months
Secondary outcomes:
measure: The change to cannabis craving assessed by the Baseline Marijuana Craving Test at the end of treatment
timeFrame: 3 month
measure: The change in cannabis craving during an incentive to use task evaluated by analog visual scale scores (0 to 10)
timeFrame: 3 months
measure: Montgomery-Åsberg depression rating scale) Scores (0 to 60)
timeFrame: 3 months
measure: evaluation of the change in the number of joints consumed per day
timeFrame: 3 months
measure: evaluation of the change in the number of cigarettes consumed per day
timeFrame: 3 months
measure: assessment of the change in attention and inhibition skills as assessed by the Stroop test before and after a neurofeedback test
timeFrame: 3 months
measure: the Gambling Task's assessment of decreased risk-taking
timeFrame: 3 months
measure: Young Mania Rating Scale Scores (0 to 60)
timeFrame: 3 months
measure: Beck Depression Inventory Scores (0 to 39)
timeFrame: 3 months
measure: Clinical Global Impression Severity of disease (0 to 7)
timeFrame: 3 months
Other outcomes:
Locations:
city: Maisons Alfort
country: France
facility: Youcef BENCHERIF
state: Île De France
Study officials:
affiliation: Clinical Unite research of EPS Ville Evrard
name: Noomane BOUAZIZ
role: PRINCIPAL_INVESTIGATOR
References: