Efficacy of Repetitive Transcranial Magnetic Stimulation in Reducing Cocaine Intake in Addicted Patients (MagneTox)

Azienda Ospedaliero-Universitaria Careggi

Status: Completed

Conditions: Cocaine Use Disorder

Treatments: Other: rTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT03607591

CEAVC SPE 16.309

Details and patient eligibility

About

The study evaluates the efficacy of 3 weeks of repetitive transcranial magnetic stimulation (rTMS), 5 sessions/weekly, in reducing cocaine consumption immediately after and within the 8 weeks following the treatment in addicted patients with cocaine use disorders (CUD) versus placebo.

Full description

40 patients are expected and randomized in two groups: 20 patients with active rTMS and 20 with placebo rTMS.

Visit 1: 15 days (3 weeks of 5 consecutive daily sessions and 2 days of rest) 15Hz rTMS is performed during the following days in addition to a biweekly urine drug test and VAS evaluation.

Visit 2: Changes from baseline to week 8 in cocaine intake. Evaluation of craving and of other assessments like mood and quality of life.

Enrollment: 65 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male and female patients between 18 and 65 years of age
• patients who meet the criteria for CUD reported in the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-V)
• positivity to cocaine use, determined via an urine drug test
• patients who are able to provide a written informed consent, after being notified about the treatment and the study protocol

Exclusion criteria

• major depression disorder, schizophrenia, bipolar disorder or other psychosis that meet the diagnostic criteria of the DSM-V
• illiteracy or cognitive impairment disorders
• women who are pregnant or lactating
• other medical diseases that contraindicate rTMS treatment such as epilepsy
• presence of devices, i.e. pace-makers or cochlear prosthesis
• previous rTMS treatments in order to avoid confounding factors
• patients who can not provide the written informed consent
• DSM-V substance use disorders other than CUD. Only tobacco smoke is allowed to be recruited in the study protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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65 participants in 2 patient groups, including a placebo group

Active rTMS group

Active Comparator group

Description:

One daily session: active 15Hz frequency, pulse intensity 100% of the rTMS, 60 pulses per train, inter-train pause of 15 sec, 40 stimulation trains for a total of 2400 pulses in 13 min of stimulation). 15 sessions (3 weeks of 5 consecutive daily sessions and 2 days of rest)

Treatment:

Other: rTMS

Placebo rTMS group

Placebo Comparator group

Description:

One daily session: inactive 15Hz frequency, pulse intensity 100% of the rTMS, 60 pulses per train, inter-train pause of 15 sec, 40 stimulation trains for a total of 2400 pulses in 13 min of stimulation). 15 sessions (3 weeks of 5 consecutive daily sessions and 2 days of rest)

Treatment:

Other: rTMS