rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder
COAST
Augmenting Cognitive-behavioral Therapy With rTMS of the Medial Prefrontal and Anterior Cingulate Cortices for the Treatment of Cocaine Use Disorder
2 other identifiers
interventional
30
1 country
1
Brief Summary
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.
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 Aug 2026
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
August 14, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 28, 2028
August 17, 2026
August 1, 2026
1.7 years
July 26, 2023
August 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Percentage of participants receiving at least 15 out of 20 rTMS sessions
Feasibility will be measured as the total percentage of participants who receive the defined number of rTMS sessions
1 week
Number of participants experiencing an rTMS-emergent serious adverse event
Safety of rTMS will be measured by the absolute number of serious adverse events that occur in the active rTMS arm
1 week
Number of participants with 15% decrease in RSFC (resting state functional connectivity) between the DLPFC (dorsolateral prefrontal cortex) and anterior cingulate.
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
1 week
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 consecutive weeks of abstinence, as defined by no self-reported cocaine use using the timeline follow-back method and confirmed by qualitative urine benzoylecgonine screening
12 weeks
Study Arms (2)
Active iTBS rTMS
ACTIVE COMPARATORDaily repetitive transcranial magnetic brain stimulation for 1 week (20 sessions).
Sham (placebo) rTMS
PLACEBO COMPARATORSham rTMS uses the same device and mimics the auditory and scalp sensations without stimulating the brain.
Interventions
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.
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.
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 and/or breast feeding
- Clinically significant abnormal cardiac functioning per electrocardiogram (ECG) (required for any participant age 60 years and older);
- Other conditions associated with seizure: epilepsy and the following acute or subacute neurologic disorders: stroke (ischemic or hemorrhagic), multiple sclerosis, traumatic brain injury (moderate or severe), neurosurgery, meningoencephalitis, increased intracerebral pressure, or intracerebral abscess, neurodegenerative disorders, and parenchymal or leptomeningeal brain tumors (per the TMS core guidelines which is attached).
- Participants with a history of metabolic abnormalities (hyponatremia, hypocalcemia, hypomagnesemia, hypo or hyperglycemia, renal failure/uremia, liver failure), recent infection with fever, and serious alcohol withdrawal will be assessed by the MD/NP to ensure these conditions have resolved and are not currently present (per the TMS core guidelines which is attached).
- In this protocol, we will also exclude glaucoma, severe migraine (particularly complicated migraines with significant aura and hemiparesis, and severe vertebrobasilar migraines, that may lead to brainstem infarctions).
- Medications that lower seizure threshold and in the opinion of the investigator impose significant seizure risk for the individual (including tricyclic antidepressants, monoamine oxidase inhibitors, bupropion, clozapine, and anticholinergics). The use of lithium, antipsychotics (other than clozapine), antibiotics, antihistamines, selective serotonin reuptake inhibitors, and serotonin-norepinephrine reuptake inhibitors will be carefully assessed by the physician
- Cognitive disorder (MMSE \<25);
- Disqualifying response on the TMS Adult Safety Screen (TASS);
- +6 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
August 14, 2026
Primary Completion (Estimated)
April 28, 2028
Study Completion (Estimated)
April 28, 2028
Last Updated
August 17, 2026
Record last verified: 2026-08
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).