ClinicalTrials.gg
RecruitingNCT05974202COASTUpdated Nov 2, 2026

rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder

An interventional study of Active H7-coil repetitive transcranial magnetic stimulation (rTMS) and Sham H7-coil repetitive transcranial magnetic stimulation (rTMS) in Cocaine Use, Cocaine Dependence and Cocaine Use Disorder, sponsored by New York State Psychiatric Institute. Recruiting at 1 site in United States. Open to participants aged 22 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by New York State Psychiatric Institute · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Updated Oct 22, 2026Eligibility revisedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
22 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

Cocaine use disorder (CUD) is significant public health problem in the U.S. There are no FDA approved medications and many people fail to respond to behavioral therapies, meaning that effective treatment strategies are needed. Previous studies have shown that transcranial magnetic stimulation (rTMS) can reduce cocaine use, although many of these studies have been preliminary and didn't have a control group using sham (placebo) rTMS. Thus, the goal of this study is to use a controlled design to assess rTMS as a treatment. Furthermore, we will use the H-7 coil, which is currently FDA cleared for the treatment for obsessive-compulsive disorder (OCD) and major depressive disorder

The trial will use an accelerated protocol to deliver rTMS, where multiple sessions are delivered in a single day [Roth et al, 2023, Cole et al. 2022]. Previous studies delivered up to 10 sessions per day [Cole et al., 2022]. In this study, we will deliver up to 5 sessions daily, which has been done previously using the H coil [Roth et al., 2023]. Accelerated protocols can decrease the time to improvement from weeks to about 5 days [Roth et al., 2023].

This is a randomized, double-blind, sham-controlled trial to evaluate the feasibility, neural mechanism, and clinical efficacy of H-7 coil repetitive transcranial magnetic stimulation (rTMS) in 30 individuals with cocaine use disorder (CUD) when used as an augmentation to standardized cognitive-behavioral therapy (CBT). After informed consent, participants will be randomized 2:1 to active iTBS rTMS (n=20) or sham rTMS (n=10). They will undergo baseline assessments and fMRI scans, followed by 1 week of rTMS (up to 5 sessions a day), followed by 12 weeks of weekly in-person or virtual (telemedicine) CBT, for a total of 13 weeks. fMRI scans will be repeated after the rTMS week and before initiating CBT. One brief phone assessment will be completed at week 17.

02

Conditions studied

  • Cocaine Use
  • Cocaine Dependence
  • Cocaine Use Disorder
  • Cocaine Use Disorder, Moderate
  • Cocaine Use Disorder, Severe

Keywords

  • Repetitive transcranial magnetic stimulation
  • rTMS
  • TMS
  • Cognitive behavioral therapy
  • CBT
  • Functional magnetic resonance imaging
  • fMRI
03

In context

Cocaine-Related Disorders

416 studies on the registry are indexed under Cocaine-Related Disorders; 12 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 313 interventional studies indexed under Cocaine-Related Disorders.

Browse Cocaine-Related Disorders studies →

Lead sponsor

New York State Psychiatric Institute is the lead sponsor of 435 studies on the registry; 27 are open to participants now.

Of its 51 completed or terminated interventional studies of FDA-regulated products, 45 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 22, 2026. See what changed

Ages eligible
22 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 22-65;
  2. Able to give and comply with study procedures;
  3. Meets 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 must agree to use a method of with proven efficacy and agree to not become pregnant during the study.

Exclusion criteria

Exclusion Criteria:

  1. Meets 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;
  9. Significant current risk of suicide, 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 year that, in the opinion of the clinician, increases risk of future suicidal behavior over the study period (note: non-suicidal self-injurious behavior is not exclusionary).
  10. Females with a positive urine pregnancy test and/or breast feeding
  11. abnormal cardiac functioning per (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 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 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).

  14. 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
  15. Cognitive disorder ( \<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, implanted brain stimulators)
  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.
  22. Moderate to severe heart disease
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    Active iTBS rTMS

    Daily repetitive transcranial magnetic brain stimulation for 1 week (20 sessions).

    Device: Active H7-coil repetitive transcranial magnetic stimulation (rTMS)

  • Placebo comparator
    Sham (placebo) rTMS

    Sham rTMS uses the same device and mimics the auditory and scalp sensations without stimulating the brain.

    Device: Sham H7-coil repetitive transcranial magnetic stimulation (rTMS)

Interventions

  • DeviceActive H7-coil repetitive transcranial magnetic stimulation (rTMS)

    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.

  • DeviceSham H7-coil repetitive transcranial magnetic stimulation (rTMS)

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 week

  2. 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

    Time frame: 1 week

  3. 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

    Time frame: 1 week

  4. 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

    Time frame: 12 weeks

07

Study locations

1 of 1 sites recruiting
  • New York State Psychiatric Institute (NYSPI) / Substance Treatment and Research Service (STARS)
    New York, New York 10019, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Individual participant data that underlie the results published in this report (after de-identification) (text, tables, figures).

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

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.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Eligibility
1 inclusion criterion edited; 4 exclusion criteria edited
What changed in the criteria
Inclusion criteria
  • EditedUsed cocaine at least 96 days in the past 28 days, with at least weekly cocaine use;
Exclusion criteria
  • EditedMeets DSM-5 criteria for current moderate/ or severe major depressive episodedisorder, OCD, bipolar disorder, schizophrenia, or any psychotic disorder (other than transient psychosis due to substance use);
  • EditedMeets DSM-5 criteria for current moderate/ or severe other substance use disorder (aside from tobacco use disorder;). Thus physiologic dependence on any other substance other than nicotine, including alcohol, is exclusionary (including alcohol);
  • EditedMore than twice weekly use of nonNon-prescribed medications/drugs that in the opinion of the investigator may change the seizure threshold, including benzodiazepines, barbiturates, GHB/GBL, amphetamines/methamphetamine;
  • EditedAny other current DSM-5 psychiatric disorder(s) that meet the following criteria in the investigator's judgmentopinion 1) are unstable, 2) would be disruptedworsened by study procedures, or 3) are likely to require pharmacotherapy or psychotherapyacute intervention during the study period;
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    Eligibility 1 inclusion criterion edited; 4 exclusion criteria edited
    What changed in the criteria
    Inclusion criteria
    • EditedUsed cocaine at least 96 days in the past 28 days, with at least weekly cocaine use;
    Exclusion criteria
    • EditedMeets DSM-5 criteria for current moderate/ or severe major depressive episodedisorder, OCD, bipolar disorder, schizophrenia, or any psychotic disorder (other than transient psychosis due to substance use);
    • EditedMeets DSM-5 criteria for current moderate/ or severe other substance use disorder (aside from tobacco use disorder;). Thus physiologic dependence on any other substance other than nicotine, including alcohol, is exclusionary (including alcohol);
    • EditedMore than twice weekly use of nonNon-prescribed medications/drugs that in the opinion of the investigator may change the seizure threshold, including benzodiazepines, barbiturates, GHB/GBL, amphetamines/methamphetamine;
    • EditedAny other current DSM-5 psychiatric disorder(s) that meet the following criteria in the investigator's judgmentopinion 1) are unstable, 2) would be disruptedworsened by study procedures, or 3) are likely to require pharmacotherapy or psychotherapyacute intervention during the study period;
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05974202
Responsible party
John Mariani MD (Professor of Clinical Psychiatry, New York State Psychiatric Institute) — Principal investigator
First posted
Aug 3, 2023
Start date
Aug 14, 2026
Primary completion
Apr 28, 2028 (estimated)
Completion
Apr 28, 2028 (estimated)
Last update
Nov 2, 2026

Study contacts

Daniel Brooks, LCSW
Contact
daniel.brooks@nyspi.columbia.edu
646-774-8181
Amy Mahony, LMHC
Contact
amy.mahony@nyspi.columbia.edu
212-923-3031
John Mariani, MD
principal investigator · New York State Psychiatric Institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion