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

Azienda Ospedaliero-Universitaria Careggi65 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Cocaine Use Disorder

Interventions

rTMSOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

AOU Careggi

Florence, Italy

Outcomes

Primary Outcomes

Cocaine intake

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

Time frame: 8 weeks following the treatment

Secondary Outcomes

Craving first measure

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

Time frame: 8 weeks following the treatment

Craving second measure

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.

Time frame: 8 weeks following the treatment

Data from ClinicalTrials.gov

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