rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder
Eligible age
22–65 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: New York State Psychiatric Institute
You may qualify if…
- ✓ 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 6 days in the past 28 days;
- ✓ 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 not become pregnant during the study.
You may not qualify if…
- ✕ 1. Meets DSM-5 criteria for current moderate or severe major depressive disorder, OCD, bipolar disorder, schizophrenia, or any psychotic disorder (other than transient psychosis due to substance use);
- ✕ 2. Hamilton Depression Rating Scale score \> 17;
- ✕ 3. Young Mania Rating Scale score \>10;
- ✕ 4. Meets DSM-5 criteria for current moderate or severe other substance use disorder (aside from tobacco use disorder). Thus physiologic dependence on any substance other than nicotine is exclusionary (including alcohol);
- ✕ 5. Heavy weekly alcohol drinking as defined by an average of \>14 drinks/week for men or \>7 drinks/week for women on average during the past 28 days;
- ✕ 6. Prior alcohol, benzodiazepine, or barbiturate withdrawal that resulted in hospitalization, medical detoxification, or resulted in seizures or delirium tremens;
- ✕ 7. Non-prescribed medications/drugs that in the opinion of the investigator may change the seizure threshold, including benzodiazepines, barbiturates, GHB/GBL, amphetamines/methamphetamine;
- ✕ 8. Any current DSM-5 psychiatric disorder(s) that meet the following criteria in the investigator's opinion 1) are unstable, 2) would be worsened by study procedures, or 3) are likely to require acute intervention during the study period;
Where it's recruiting
New York
Source: ClinicalTrials.gov · NCT05974202 · last updated 2026-10-22