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

A

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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