About this trial
The goal of this clinical trial is to compare the effects of active repetitive transcranial magnetic stimulation (rTMS) to sham (placebo) rTMS prior to cognitive-behavioral therapy (CBT) as a treatment for adults with cocaine use disorder. The main questions it aims to answer are:
* Is rTMS safe and feasible as an augmentation for CBT for the treatment of cocaine use disorder? * What is the brain mechanism of rTMS? * Will active rTMS (compared to sham rTMS) followed by CBT help adults with cocaine use disorder achieve abstinence from cocaine?
Participants will:
* Have two brain MRI scans; * Undergo 3 weeks of daily rTMS (or sham) treatments (15 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.
Eligibility criteria
Qualifiers
Age 22-65;
Able to give informed consent and comply with study procedures;
Meets DSM-5 criteria for current moderate/severe CUD and are treatment-seeking;
Used cocaine at least 9 days in the past 28 days, with at least weekly cocaine use;
Disqualifiers
Meets DSM-5 criteria for current moderate/severe major depressive episode, OCD, bipolar disorder, schizophrenia or any psychotic disorder other than transient psychosis due to substance use;
Hamilton Depression Rating Scale score > 17;
Young Mania Rating Scale score >10;
Meets DSM-5 criteria for current moderate/severe other substance use disorder (aside from tobacco use disorder; physiologic dependence on any other substance other than nicotine, including alcohol, is exclusionary);
Trial design
Treatments tested in this trial
- Active H7-coil repetitive transcranial magnetic stimulation (rTMS)
- Sham H7-coil repetitive transcranial magnetic stimulation (rTMS)
Treatment groups
Sponsors and collaborators
New York State Psychiatric Institute
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Columbia University
Collaborator