Evaluation of the Effect of tDCS on Cannabis Craving (TCC)

Evaluation of the Effect of tDCS on Cannabis Craving: Multicentre Randomized, Double-blind Study Versus Placebo

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.

Study Overview

• Status: Unknown
• Conditions: Addiction to Cannabis
• Intervention / Treatment: Other: Neuromodulation by tDCS

• Study Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Youcef BENCHERIF; Phone Number: 0143093232; Email: y.bencherif@epsve.fr
• Study Contact Backup: Name: Rusheenthira THAVASEELAN; Phone Number: 0143093232; Email: r.thavaseelan@epsve.fr

Study Locations

• France
  • Île De France
    • Maisons Alfort, Île De France, France, 94700
      • Recruiting
      • Youcef Bencherif
      • Contact: Youcef BENCHERIF, CRA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 63 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: tDCS active arm	Other: Neuromodulation by tDCS; 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.
PLACEBO_COMPARATOR: tDCS placebo	Other: Neuromodulation by tDCS; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluating the change from craving to cannabis. by an analog visual scale .Scores (0 to 10)	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
The change to cannabis craving assessed by the Baseline Marijuana Craving Test at the end of treatment	3 month
The change in cannabis craving during an incentive to use task evaluated by analog visual scale scores (0 to 10)	3 months
Montgomery-Åsberg depression rating scale) Scores (0 to 60)	3 months
evaluation of the change in the number of joints consumed per day	3 months
evaluation of the change in the number of cigarettes consumed per day	3 months
assessment of the change in attention and inhibition skills as assessed by the Stroop test before and after a neurofeedback test	3 months
the Gambling Task's assessment of decreased risk-taking	3 months
Young Mania Rating Scale Scores (0 to 60)	3 months
Beck Depression Inventory Scores (0 to 39)	3 months
Clinical Global Impression Severity of disease (0 to 7)	3 months

Collaborators and Investigators

• Sponsor: Januel
• Investigators: Principal Investigator: Noomane BOUAZIZ, Clinical Unite research of EPS Ville Evrard

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 17, 2018
• Primary Completion (ANTICIPATED): July 17, 2021
• Study Completion (ANTICIPATED): December 17, 2021

Study Registration Dates

• First Submitted: April 27, 2020
• First Submitted That Met QC Criteria: May 13, 2020
• First Posted (ACTUAL): May 15, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 15, 2020
• Last Update Submitted That Met QC Criteria: May 13, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Marijuana Abuse
• Other Study ID Numbers: 10477M-TCC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No