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Completed

NCT Number: NCT03607591

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

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.

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Key information

Conditions

Cocaine Use Disorder Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AOU Careggi

Florence, 50134, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rTMS

Other

rTMS is a non-invasive and safe brain stimulation technique, that uses a magnetic pulse, administrated through a coil, set on the DLPFC

Primary outcomes

  1. Cocaine intake

    Time frame: 8 weeks following the treatment

    Baseline was defined as cocaine consumption before randomization (visit 0). Baseline will be determined using an urine drug test.Changes from baseline to week 8 in cocaine intake

Secondary outcomes

  1. Craving first measure

    Time frame: 8 weeks following the treatment

    Baseline will be determined using the Visual Analogic Scale (VAS) that is a ordinal scale ranging from 0 to 10. being 0 no craving and 10 maximum craving. Changes from baseline to 8 week

  2. Craving second measure

    Time frame: 8 weeks following the treatment

    Baseline will be assessed using Cocaine Craving Questionnaire (CCQ), that is a ordinal scale ranging from 0 and 45, being 0 no craving and 45 maximum craving.

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria Careggi

Other

Registry information

Official study title

Efficacy of High Frequency (15Hz) Repetitive Transcranial Magnetic Stimulation of Left Dorsolateral Prefrontal Cortex in Decreasing Intake in Patients With Cocaine Use Disorder: Study Protocol for a Randomized Placebo Controlled Trial

Acronym: MagneTox

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 31, 2018
Registry last updated
Jul 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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