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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
ISRCTN15823943 |
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Date of registration:
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13/05/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Repetitive transcranial magnetic stimulation (rTMS) in cocaine abusers
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Scientific title:
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Pilot study on reducing the craving for a group of COCAine-dependent patients treated with repetitive transcranial magnetic stimulation (rTMS) |
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Date of first enrolment:
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01/08/2014 |
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Target sample size:
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32 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN15823943 |
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Study type:
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Interventional |
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Study design:
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Between-subject open-label randomised clinical trial (Treatment)
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Phase:
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Countries of recruitment
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Italy
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Contacts
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Name:
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Luigi
Gallimberti |
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Address:
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Piazza Castello 16
35141
Padova
Italy |
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Telephone:
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+39 (0)392 9247378 |
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Email:
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studio@studiogallimberti.it |
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Affiliation:
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Name:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Diagnosis of current cocaine use disorder (CUD) based on the DSM-5
2. Seeking treatment for cocaine use
Exclusion criteria: 1. Pregnancy
2. Lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, psychosis or other psychiatric disorders
3. Diagnosis of current alcohol and/or substance use disorder (except for cocaine and smoking) based on the DSM-5
4. Diagnosis of epilepsy/seizure
5. Presence of devices, e.g. pace-makers, cochlear prosthesis, neuro-stimulators, magnetic cochlear prosthesis, intraocular metallic fragments
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cocaine use disorder (CUD)
Mental and Behavioural Disorders
Mental and behavioural disorders due to use of cocaine: dependence syndrome
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Intervention(s)
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1. Group 1 (intervention group) will be treated with rTMS (MagVenture MagPro 30 model, B-70 Cool coil). The standards used for the stimulation were the following: 15 Hz frequency, impulse intensity equal to 100% of the rMT, 60 impulses per stimulation train, intertrain pause of 15 seconds, 40 stimulation trains, 2400 total impulses for a total duration of 13 minutes.
2. Group 2 (control group) will be treated with a standard protocol used for many years at the Department of Neurology where the study was conducted in Padua, Italy. This protocol includes pharmacological treatment with pramipexole 0.35 mg t.i.d., bupropione 150 mg daily, oxazepam 15 mg t.i.d., triazolam 0.25 mg daily and gamma hydroxybutyrate 1.75 gram daily.
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Primary Outcome(s)
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Use of cocaine assessed by either positive or negative urine drug screen test for cocaine compared in the rTMS versus control groups.
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Secondary Outcome(s)
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Craving for cocaine using a 0-10 Visual Analogue Scale.
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Secondary ID(s)
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3165/AO/14
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Source(s) of Monetary Support
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Hospital of Padova Neurology Clinic (Clinica Neurologica - Azienda Ospedaliera di Padova) (Italy), Novella Fronda Foundation - ONLUS (Italy)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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