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

Not Applicable

Completed

• Conditions: Cocaine Use Disorder
• Interventions: Other: rTMS

• Registration Number: NCT03607591
• Lead Sponsor: Azienda Ospedaliero-Universitaria Careggi

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-01-08
• Study First Submitted: 2018-04-13
• Study First Submitted QC: 2018-07-22
• Study First Posted: 2018-07-31
• Primary Completion: 2020-04-01
• Study Completion: 2020-04-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-08
• Last Update Posted: 2020-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active rTMS group	rTMS	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)
Placebo rTMS group	rTMS	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)

Primary Outcome Measures

Name	Time	Method
Cocaine intake	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 Outcome Measures

Name	Time	Method
Craving first measure	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
Craving second measure	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.

Trial Locations

Locations (1)

AOU Careggi; 🇮🇹 Firenze, Italy