Efficacy of Repetitive Transcranial Magnetic Stimulation in Reducing Cocaine Intake in Addicted Patients
NCT ID: NCT03607591
Last Updated: 2020-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
65 participants
INTERVENTIONAL
2018-01-08
2020-04-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active rTMS group
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)
rTMS
rTMS is a non-invasive and safe brain stimulation technique, that uses a magnetic pulse, administrated through a coil, set on the DLPFC
Placebo rTMS group
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)
rTMS
rTMS is a non-invasive and safe brain stimulation technique, that uses a magnetic pulse, administrated through a coil, set on the DLPFC
Interventions
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rTMS
rTMS is a non-invasive and safe brain stimulation technique, that uses a magnetic pulse, administrated through a coil, set on the DLPFC
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Azienda Ospedaliero-Universitaria Careggi
OTHER
Responsible Party
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Antonello Grippo
Medical Doctor
Locations
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AOU Careggi
Florence, , Italy
Countries
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References
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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.
Other Identifiers
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CEAVC SPE 16.309
Identifier Type: -
Identifier Source: org_study_id
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