rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder

The goal of the study is to investigate the feasibility, safety, and effect of rTMS on mPFC/dACC activity using a combination of fMRI and clinical outcome measures, when used as an augmentation to CBT. Our hypothesis is that we will meet the following milestones prior to moving forward to the UH3 phase (a clinical trial for CUD). * Feasibility: At least 75% of participants will receive at least 15 out of 20 rTMS sessions with no participants experiencing a study-related serious adverse event * Mechanism: Compared to baseline, after 1 week of rTMS, participants who received active rTMS will demonstrate a 15% decrease in RSFC (resting state functional connectivity) between the DLPFC (dorsolateral prefrontal cortex) and anterior cingulate * Efficacy: During the final 12 weeks of the trial (weeks 2-13), at least 15% of participants who received active rTMS will demonstrate 3 consecutive weeks of abstinence Participants will: * Have two brain MRI scans; * Undergo 1 week of daily rTMS (or sham) treatments (up to 20 sessions), and; * Have 12 weeks of once-weekly cognitive-behavioral therapy for the treatment of cocaine use disorder. Researchers will compare active (real) rTMS to sham (placebo) rTMS. All participants will receive cognitive-behavioral therapy. The former principle investigator, Dr. Derek Blevins, has vacated his position (February 2025), and has transferred the principle investigator role to Dr. John Mariani, the STARS Clinic Director.

NCT Number	NCT05974202
Lead Sponsor	New York State Psychiatric Institute Collaborators: National Institute on Drug Abuse (NIDA), Columbia University
Conditions	Cocaine Use, Cocaine Dependence, Cocaine Use Disorder, Cocaine Use Disorder, Moderate, Cocaine Use Disorder, Severe
Enrollment	30 participants
Start Date	2026-08-14
Primary Completion	2028-04-28 (estimated)
Study Completion	2028-04-28 (estimated)
Updated on ClinicalTrials.gov	2026-08-14