Augmenting Cognitive-behavioral Therapy With rTMS of the Medial Prefrontal and Anterior Cingulate Cortices for the Treatment of Cocaine Use Disorder
New York State Psychiatric Institute
Summary
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.
Description
Cocaine use disorder (CUD) remains a significant public health problem given that many patients fail to respond to existing therapies (Dutra et al., 2008). Treatment refractory CUD may be explained, in part, by abnormal neurocircuitry. The medial prefrontal cortex (mPFC) and dorsal anterior cingulate cortex (dACC) have demonstrated altered functioning in CUD (Hanlon et al., 2016). Compared to controls, participants with CUD show consistent changes to the mPFC/dACC, including hypoactivation during cognitive and attentional tasks (Bolla et al., 2003; Kaufman et al., 2003; Kubler et al., 2005), h…
Eligibility
- Age range
- 22–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age 22-65; 2. Able to give informed consent and comply with study procedures; 3. Meets DSM-5 criteria for current moderate/severe CUD and are treatment-seeking; 4. Used cocaine at least 9 days in the past 28 days, with at least weekly cocaine use; 5. Agree to no more than moderate alcohol consumption (\<15 drinks/week for men and \<8 drinks/week for women) and to avoid using amphetamine/methamphetamine and non-prescribed benzodiazepines or barbiturates; and 6. Women of childbearing potential must agree to use a method of contraception with proven efficacy and agree to n…
Interventions
- DeviceActive H7-coil repetitive transcranial magnetic stimulation (rTMS)
A magnetic current created by the device creates an electrical current in the brain to stimulate the medial prefrontal cortex and dorsal anterior cingulate cortex.
- DeviceSham H7-coil repetitive transcranial magnetic stimulation (rTMS)
A 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.
Location
- New York State Psychiatric Institute (NYSPI) / Substance Treatment and Research Service (STARS)New York, New York