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.
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;
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);
Parallel
Active H7-coil repetitive transcranial magnetic stimulation (rTMS)
DeviceA magnetic current created by the device creates an electrical current in the brain to stimulate the medial prefrontal cortex and dorsal anterior cingulate cortex.
Sham H7-coil repetitive transcranial magnetic stimulation (rTMS)
DeviceA sham coil is in the same helmet as the active coil. The sham coil mimics the sound, scalp sensations, and facial muscle activation caused by the active coil, but does not create an electrical current in the brain.
Percentage of participants receiving at least 10 out of 15 rTMS sessions
Feasibility will be measured as the total percentage of participants who receive the defined number of rTMS sessions
Number of participants in the active rTMS arm experiencing an rTMS-emergent adverse event
Safety of rTMS will be measured by the absolute number of serious adverse events that occur in the active rTMS arm
Percent change of medial prefrontal cortex and dorsal anterior cingulate cortex activity on fMRI during the Drug Stroop Task
Neural mechanism will be evaluated by comparing the active and sham rTMS groups during the fMRI task by comparing baseline fMRI and post-rTMS fMRI measures
Percentage of participants who achieve 3 weeks of abstinence during the final 12 weeks of the trial
Efficacy regarding cocaine use outcomes will be evaluated by comparing the active and sham rTMS groups during the final 12 weeks of the trial while the participants are receiving cognitive behavioral therapy. 3 weeks of consecutive abstinence is defined as: 1. No cocaine use is self-reported per timeline followback; 2. At least 6 urine drug screens are completed during the 3 weeks of continuous abstinence, and all are negative (with the exception of any positive urine in the first 4 days of the first week of the three weeks of self-reported abstinence, as urine may remain positive for up to 4 days after an episode of use), and; 3. At least 1 urine drug screen is completed each week during the 3 weeks of self-reported continuous abstinence.
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New York State Psychiatric Institute
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Columbia University
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
