rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder
Augmenting Cognitive-behavioral Therapy With rTMS of the Medial Prefrontal and Anterior Cingulate Cortices for the Treatment of Cocaine Use Disorder
1 other identifier
interventional
30
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2023
CompletedFirst Posted
Study publicly available on registry
August 3, 2023
CompletedStudy Start
First participant enrolled
December 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
August 3, 2025
August 1, 2025
1.3 years
July 26, 2023
August 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
3 weeks
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
3 weeks
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
3 weeks
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.
12 weeks
Study Arms (2)
Active (high-frequency) rTMS
ACTIVE COMPARATORDaily high-frequency (10 Hz) repetitive transcranial magnetic brain stimulation for 3 weeks (15 sessions).
Sham (placebo) rTMS
PLACEBO COMPARATORSham rTMS uses the same device and mimics the auditory and scalp sensations without stimulating the brain.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- 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;
- Females with a positive urine pregnancy test;
- Clinically significant abnormal cardiac functioning per electrocardiogram (ECG) (required for any participant age 60 years and older);
- 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);
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- New York State Psychiatric Institutelead
- National Institute on Drug Abuse (NIDA)collaborator
- Columbia Universitycollaborator
Study Sites (1)
New York State Psychiatric Institute (NYSPI) / Substance Treatment and Research Service (STARS)
New York, New York, 10019, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Mariani, MD
New York State Psychiatric Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double-blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Clinical Psychiatry
Study Record Dates
First Submitted
July 26, 2023
First Posted
August 3, 2023
Study Start
December 15, 2025
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
August 3, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Beginning twelve months and ending 5 years after article publication.
- Access Criteria
- To researcher who provides a methodologically sound proposal to achieve aims in approved proposal.
Individual participant data that underlie the results published in this report (after de-identification) (text, tables, figures).