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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active rTMS group | Active Comparator | 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 | Placebo Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rTMS | Other | rTMS is a non-invasive and safe brain stimulation technique, that uses a magnetic pulse, administrated through a coil, set on the DLPFC |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Craving second measure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU Careggi | Florence | 50134 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34784373 | Derived | 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. |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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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 |