rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder

Launched by NEW YORK STATE PSYCHIATRIC INSTITUTE · Jul 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help adults with cocaine use disorder by combining a treatment called repetitive transcranial magnetic stimulation (rTMS) with cognitive-behavioral therapy (CBT). rTMS is a non-invasive procedure that uses magnetic fields to stimulate certain parts of the brain. Researchers want to find out if active rTMS is safe and if it works better than a placebo (sham rTMS) in helping people stop using cocaine. Participants will have two brain scans (MRIs), receive rTMS or sham treatment daily for three weeks, and then attend weekly CBT sessions for 12 weeks.

To join the study, participants must be between 22 and 65 years old, be seeking treatment for their cocaine use, and have used cocaine regularly in the past month. They should also agree to limit alcohol and avoid certain other drugs during the study. However, individuals with specific mental health conditions, significant alcohol use, or certain medical issues may not be eligible. This trial is not yet recruiting participants, but it aims to help improve treatment options for cocaine use disorder by understanding how rTMS affects the brain and its potential benefits in conjunction with therapy.

Gender

ALL

Eligibility criteria

• 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 not become pregnant during the study.
• Exclusion Criteria:
• • 1. 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;
• • 2. Hamilton Depression Rating Scale score \> 17;
• • 3. Young Mania Rating Scale score \>10;
• • 4. 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);
• • 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. More than twice weekly use of non-prescribed medications/drugs that may change the seizure threshold, including benzodiazepines, barbiturates, GHB/GBL, amphetamines/methamphetamine;
• • 8. Any other current DSM-5 psychiatric disorder(s) that in the investigator's judgment are unstable, would be disrupted by study procedures, or are likely to require pharmacotherapy or psychotherapy during the study period;
• • 9. Significant current suicide risk, indicated by either: (1) "yes" response on #3, 4, or #5 on the C-SSRS and a psychiatric risk assessment indicating a moderate or high risk of suicide or (2) suicidal behavior in the past 3 months (note: non-suicidal self-injurious behavior is not exclusionary);
• • 10. Females with a positive urine pregnancy test;
• • 11. Clinically significant abnormal cardiac functioning per electrocardiogram (ECG) (required for any participant age 60 years and older);
• • 12. Seizure history including: seizure disorder/epilepsy, alcohol/drug withdrawal seizure, or seizure deemed by the study physician to be related to cocaine intoxication/withdrawal (note: febrile seizures are not exclusionary)
• • 13. Other medical conditions that are relatively contraindicated with TMS (seizure disorders, glaucoma, increased intracranial pressure, severe migraines, stroke, brain lesions, pregnancy or breast-feeding, neurodegenerative disease, meningoencephalitis, intracerebral abscess, parenchymal or leptomeningeal cancers);
• • 14. Medications that lower seizure threshold and in the opinion of the investigator impose significant seizure risk for the individual (including bupropion, antipsychotics, lithium, anticholinergics, and tricyclic antidepressants);
• • 15. Cognitive disorder (MMSE \<25);
• • 16. Disqualifying response on the TMS Adult Safety Screen (TASS);
• • 17. Implanted devices or stimulators (cardiac pacemakers, vagus nerve stimulators, spinal cord stimulators, cochlear implant);
• • 18. Currently taking ototoxic medications (aminoglycosides, cisplatin);
• • 19. Metal implants or paramagnetic objects in the body that prohibits MR scanning;
• • 20. Claustrophobia that prohibits MR scanning; or
• • 21. Legally mandated (e.g., to avoid incarceration or other penalties) to participate in SUD treatment program.