Trials / Completed
CompletedNCT03607591
Efficacy of Repetitive Transcranial Magnetic Stimulation in Reducing Cocaine Intake in Addicted Patients
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 65 (actual)
- Sponsor
- Azienda Ospedaliero-Universitaria Careggi · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | rTMS | rTMS is a non-invasive and safe brain stimulation technique, that uses a magnetic pulse, administrated through a coil, set on the DLPFC |
Timeline
- Start date
- 2018-01-08
- Primary completion
- 2020-04-01
- Completion
- 2020-04-01
- First posted
- 2018-07-31
- Last updated
- 2020-07-09
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT03607591. Inclusion in this directory is not an endorsement.