Evaluation of the Effect of tDCS on Cannabis Craving

NCT ID: NCT04389528

Last Updated: 2020-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-17

Study Completion Date

2021-12-17

Brief Summary

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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.

Detailed Description

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Conditions

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Addiction to Cannabis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

double-blind randomized study
Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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tDCS active arm

Group Type EXPERIMENTAL

Neuromodulation by tDCS

Intervention Type 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 placebo

Group Type PLACEBO_COMPARATOR

Neuromodulation by tDCS

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

63 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Januel

OTHER

Sponsor Role lead

Responsible Party

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Januel

Head of the clinical research unit of ville evrard

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Noomane BOUAZIZ

Role: PRINCIPAL_INVESTIGATOR

Clinical Unite research of EPS Ville Evrard

Locations

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Youcef BENCHERIF

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

Site Status RECRUITING

Countries

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France

Central Contacts

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Youcef BENCHERIF

Role: CONTACT

0143093232

Rusheenthira THAVASEELAN

Role: CONTACT

0143093232

Facility Contacts

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Youcef BENCHERIF, CRA

Role: primary

Other Identifiers

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10477M-TCC

Identifier Type: -

Identifier Source: org_study_id

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