Addiction to CannabisTCCNCT04389528
Evaluation of the Effect of tDCS on Cannabis Craving
A study testing Neuromodulation by tDCS in people with Addiction to Cannabis, run by Januel at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 63 yearsHealthy volunteers can take part
- Conditions the study is for
- Addiction to Cannabis
- What is being tested?
- Neuromodulation by tDCS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteFrance
- Study dates
- 17 Sep 2018to 17 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 63 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Youcef BENCHERIF
Maisons-Alfort, Île-de-France Region, 94700
Youcef BENCHERIF, CRA
About this study
Official title: 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.
Read more
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
- Being tested
- Neuromodulation by tDCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromodulation by tDCSOther
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.
| Study group | Role | What they receive |
|---|---|---|
| tDCS active arm | Experimental | Not described Receives: Other: Neuromodulation by tDCS |
| tDCS placebo | Placebo comparator | Not described Receives: Other: Neuromodulation by tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating the change from craving to cannabis. by an analog visual scale .Scores (0 to 10)
Measured: 3 months
Secondary outcomes (10)
The change to cannabis craving assessed by the Baseline Marijuana Craving Test at the end of treatment
Measured: 3 month
The change in cannabis craving during an incentive to use task evaluated by analog visual scale scores (0 to 10)
Measured: 3 months
Montgomery-Åsberg depression rating scale) Scores (0 to 60)
Measured: 3 months
evaluation of the change in the number of joints consumed per day
Measured: 3 months
evaluation of the change in the number of cigarettes consumed per day
Measured: 3 months
assessment of the change in attention and inhibition skills as assessed by the Stroop test before and after a neurofeedback test
Measured: 3 months
the Gambling Task's assessment of decreased risk-taking
Measured: 3 months
Young Mania Rating Scale Scores (0 to 60)
Measured: 3 months
Beck Depression Inventory Scores (0 to 39)
Measured: 3 months
Clinical Global Impression Severity of disease (0 to 7)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start17 Sep 2018
- Primary completion17 Jul 2021 (estimated)
- Study completion17 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Addiction to CannabisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double-blind randomized study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Januel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Januel, Centre hospitalier de Ville-Evrard, France
- Investigators
- Noomane BOUAZIZ, Principal investigator, Clinical Unite research of EPS Ville Evrard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04389528
- Sponsor's protocol ID
- 10477M-TCC
- Acronym
- TCC
- Status last verified
- May 2020
- First submitted
- 27 Apr 2020
- Last updated
- 15 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of tDCS on Cannabis Craving: Multicentre Randomized, Double-blind Study Versus Placebo
- ClinicalTrials.gov ID
- NCT04389528
- Acronym / sponsor ID
- TCC / 10477M-TCC
- Conditions
- Addiction to Cannabis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- JanuelUniversity, hospital or other
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 17 Jul 2021 (estimated)
- Study completion
- 17 Dec 2021 (estimated)
- First posted
- 15 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double-blind randomized study
| Arm | Type | Receives |
|---|---|---|
| tDCS active arm | Experimental | Other: Neuromodulation by tDCS |
| tDCS placebo | Placebo comparator | Other: Neuromodulation by tDCS |
Who may qualify
- Ages
- 18 to 63 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromodulation by tDCSThe 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. | Other | tDCS active arm, tDCS placebo |
Primary outcome
Evaluating the change from craving to cannabis. by an analog visual scale .Scores (0 to 10)
Time frame: 3 months
10 secondary outcomes
The change to cannabis craving assessed by the Baseline Marijuana Craving Test at the end of treatment
Time frame: 3 month
The change in cannabis craving during an incentive to use task evaluated by analog visual scale scores (0 to 10)
Time frame: 3 months
Montgomery-Åsberg depression rating scale) Scores (0 to 60)
Time frame: 3 months
evaluation of the change in the number of joints consumed per day
Time frame: 3 months
evaluation of the change in the number of cigarettes consumed per day
Time frame: 3 months
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
the Gambling Task's assessment of decreased risk-taking
Time frame: 3 months
Young Mania Rating Scale Scores (0 to 60)
Time frame: 3 months
Beck Depression Inventory Scores (0 to 39)
Time frame: 3 months
Clinical Global Impression Severity of disease (0 to 7)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noomane BOUAZIZ principal investigator
Clinical Unite research of EPS Ville Evrard
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromodulation by tDCS in people with Addiction to Cannabis, run by Januel at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Youcef BENCHERIF (0143093232, y.bencherif@epsve.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating the change from craving to cannabis. by an analog visual scale .Scores (0 to 10) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2020.