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NCT ID: NCT03333460 Recruiting - Clinical trials for Substance Use Disorders

Transcranial Magnetic Stimulation for Cocaine Addiction

BRAINSWITCH
Start date: October 1, 2017
Phase: N/A
Study type: Interventional

Background: Cocaine use disorders (CUD) is a complex brain disorder, involving several brain areas and neurocircuits. Effective treatments for CUD are still needed. Repetitive transcranial magnetic stimulation (rTMS) stimulates non-invasively parts of the brain. Preliminary data suggest that rTMS may help reducing cocaine craving and consumption. Researchers want to learn how the brain and the drug-seeking behavior may change with this treatment. Objectives: To test if rTMS can reduce cocaine craving and use, and also affect several mood, behavioral and cognitive alterations associated with prolonged cocaine use. Eligibility: Healthy, right-handed adults ages 18-65 who do have cocaine use disorder (moderate to severe). Design: This is a randomized, double-blind, sham-controlled study. The study includes three phases: 1) a rTMS continued treatment phase; a rTMS follow-up; and a no rTMS follow-up. Prior to participating, participants will be screened with: - Questionnaires - Medical history - Physical exam - Urine tests - MRI (structural) After being enrolled, baseline behavioral and imaging data will be collected. In particular, participants will undergo: - Questionnaires - Functional MRI During the continued rTMS phase, participants with cocaine use disorder will be randomized to receive real or fake rTMS. Repetitive TMS will be delivered during 10 outpatient treatment days, over 2 weeks (5 days/week). Following this phase, subjects will have 12 follow-up visits (once/weekly), during which they will receive rTMS, and behavioral and imaging assessments will be performed. At the end of the rTMS follow up period, participants will further receive 3 follow up visits (once a month), during which rTMS will not be performed, but behavioral data will be collected. Treatment includes: - rTMS: A coil is placed on the head. A brief electrical current passes through the coil. At each visit, participants will receive two rTMS sessions, with a 1hr interval between sessions. At the beginning of each rTMS session, they view cocaine-related images for few minutes. - MRIs at baseline and at follow-up visit #12: Participants lie on a table that slides into a cylinder that takes pictures of the brain. They respond to images while in the scanner. - Repeat of screening tests and questionnaires - Urine toxicological screen