Status:
NOT_YET_RECRUITING
rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Columbia University
Conditions:
Cocaine Use
Cocaine Dependence
Eligibility:
All Genders
22-65 years
Phase:
NA
Brief 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 treatmen...
Detailed 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, i...
Eligibility Criteria
Inclusion
- 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;
- 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
- 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
- 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);
- 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;
- Prior alcohol, benzodiazepine, or barbiturate withdrawal that resulted in hospitalization, medical detoxification, or resulted in seizures or delirium tremens;
- More than twice weekly use of non-prescribed medications/drugs that may change the seizure threshold, including benzodiazepines, barbiturates, GHB/GBL, amphetamines/methamphetamine;
- 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;
- 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);
- Females with a positive urine pregnancy test;
- Clinically significant abnormal cardiac functioning per electrocardiogram (ECG) (required for any participant age 60 years and older);
- 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)
- 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);
- 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);
- Cognitive disorder (MMSE \<25);
- Disqualifying response on the TMS Adult Safety Screen (TASS);
- Implanted devices or stimulators (cardiac pacemakers, vagus nerve stimulators, spinal cord stimulators, cochlear implant);
- Currently taking ototoxic medications (aminoglycosides, cisplatin);
- Metal implants or paramagnetic objects in the body that prohibits MR scanning;
- Claustrophobia that prohibits MR scanning; or
- Legally mandated (e.g., to avoid incarceration or other penalties) to participate in SUD treatment program.
Key Trial Info
Start Date :
December 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05974202
Start Date
December 15 2025
End Date
April 1 2027
Last Update
August 3 2025
Active Locations (1)
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1
New York State Psychiatric Institute (NYSPI) / Substance Treatment and Research Service (STARS)
New York, New York, United States, 10019