Evaluation of the Effect of tDCS on Cannabis Craving

NCT04389528 | Unknown

• 1 other identifier: 10477M-TCC
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Addiction to Cannabis

Outcome Measures

Primary Outcomes (1)

• Evaluating the change from craving to cannabis. by an analog visual scale .Scores (0 to 10)

  3 months

Secondary Outcomes (10)

• 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

Study Arms (2)

tDCS active arm

EXPERIMENTAL

Other: Neuromodulation by tDCS

tDCS placebo

PLACEBO COMPARATOR

Other: Neuromodulation by tDCS

Interventions

Neuromodulation by tDCS OTHER

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.

tDCS active arm; tDCS placebo

Eligibility Criteria

• Age: 18 Years - 63 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Januel: lead

Study Sites (1)

Youcef BENCHERIF

Maisons-Alfort, Île-de-France Region, 94700, France

RECRUITING

Study Officials

• Noomane BOUAZIZ

  Clinical Unite research of EPS Ville Evrard

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Youcef BENCHERIF

CONTACT

0143093232; y.bencherif@epsve.fr

Rusheenthira THAVASEELAN

CONTACT

0143093232; r.thavaseelan@epsve.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of the clinical research unit of ville evrard

Model Details: double-blind randomized study

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: May 15, 2020
• Study Start: September 17, 2018
• Primary Completion: July 17, 2021
• Study Completion: December 17, 2021
• Last Updated: May 15, 2020

Record last verified: 2020-05

Locations

FR (1)