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

Cocaine Use Disorder Clinical Trial

— MagneTox  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03607591
• Other study ID #: CEAVC SPE 16.309
• Status: Completed
• Phase: N/A
• Start date: January 8, 2018
• Est. completion date: April 1, 2020

Study information

• Verified date: July 2020
• Source: Azienda Ospedaliero-Universitaria Careggi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cocaine Use Disorder
• Disease

Intervention

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

Locations

Country	Name	City	State
Italy	AOU Careggi	Firenze

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria Careggi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	8 weeks following the treatment
Secondary	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	8 weeks following the treatment
Secondary	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.	8 weeks following the treatment