Clinical trial NCT03607591: Efficacy of Repetitive Transcranial Magnetic Stimulation in Reducing Cocaine Intake in Addicted Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cocaine Use Disorder
Keywords: rTMS
Craving
Mood and cognitive behavior
Substance-Related Disorders
Lead sponsor: Azienda Ospedaliero-Universitaria Careggi
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cocaine intake
timeFrame: 8 weeks following the treatment
Secondary outcomes:
measure: Craving first measure
timeFrame: 8 weeks following the treatment
measure: Craving second measure
timeFrame: 8 weeks following the treatment
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: AOU Careggi
Study officials:
References:
citation: Lolli F, Salimova M, Scarpino M, Lanzo G, Cossu C, Bastianelli M, Occupati B, Gori F, Del Vecchio A, Ercolini A, Pascolo S, Cimino V, Meneghin N, Fierini F, D'Anna G, Innocenti M, Ballerini A, Pallanti S, Grippo A, Mannaioni G. A randomised, double-blind, sham-controlled study of left prefrontal cortex 15 Hz repetitive transcranial magnetic stimulation in cocaine consumption and craving. PLoS One. 2021 Nov 16;16(11):e0259860. doi: 10.1371/journal.pone.0259860. eCollection 2021.