Cocaine UseCOASTNCT05974202
rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder
A study testing Active H7-coil repetitive transcranial magnetic stimulation (rTMS) in people with Cocaine Use and Cocaine Dependence, run by New York State Psychiatric Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Cocaine Use, Cocaine Dependence, Cocaine Use Disorder
- What is being tested?
- Active H7-coil repetitive transcranial magnetic stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2026to 28 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 6 days in the past 28 days;
- 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.
Who cannot join
- Meets DSM-5 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);
- Hamilton Depression Rating Scale score > 17;
- Young Mania Rating Scale score >10;
- 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);
- 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;
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- Non-prescribed medications/drugs that in the opinion of the investigator may change the seizure threshold, including benzodiazepines, barbiturates, GHB/GBL, amphetamines/methamphetamine;
- 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;
- 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).
- 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);
- 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 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);
- Implanted devices or stimulators (cardiac pacemakers, vagus nerve stimulators, spinal cord stimulators, cochlear implant, implanted brain stimulators)
- 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.
- Moderate to severe heart disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
New York State Psychiatric Institute (NYSPI) / Substance Treatment and Research Service (STARS)
New York, New York, 10019
Substance Treatment and Research Service (STARS), 212-923-3031, stars.info@nyspi.columbia.edu
Daniel Brooks, LCSW, 6467748181, daniel.brooks@nyspi.columbia.edu
About this study
Official title: Augmenting Cognitive-behavioral Therapy With rTMS of the Medial Prefrontal and Anterior Cingulate Cortices for the Treatment of Cocaine Use Disorder
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
Read more
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.
- Conditions
- Cocaine Use, Cocaine Dependence, Cocaine Use Disorder, Cocaine Use Disorder, Moderate, Cocaine Use Disorder, Severe
- Being tested
- Active H7-coil repetitive transcranial magnetic stimulation (rTMS), Sham H7-coil repetitive transcranial magnetic stimulation (rTMS)
- Keywords
- Repetitive transcranial magnetic stimulation, rTMS, TMS, Cognitive behavioral therapy, CBT, Functional magnetic resonance imaging, fMRI
- Medical subject headings
- Cocaine-Related Disorders, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active H7-coil repetitive transcranial magnetic stimulation (rTMS)Device
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.
Sham H7-coil repetitive transcranial magnetic stimulation (rTMS)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Active iTBS rTMS | Active comparator | Daily repetitive transcranial magnetic brain stimulation for 1 week (20 sessions). Receives: Device: Active H7-coil repetitive transcranial magnetic stimulation (rTMS) |
| Sham (placebo) rTMS | Placebo comparator | Sham rTMS uses the same device and mimics the auditory and scalp sensations without stimulating the brain. Receives: Device: Sham H7-coil repetitive transcranial magnetic stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start14 Aug 2026
- Primary completion28 Apr 2028 (estimated)
- Study completion28 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Active high-frequency stimulation vs. sham (placebo) stimulation
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Columbia University
- Responsible party
- Principal investigator, John Mariani MD, New York State Psychiatric Institute
- Investigators
- John Mariani, MD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974202
- Sponsor's protocol ID
- 8483/Pro00076502
- Other IDs
- UG3DA056138-01A1
- Acronym
- COAST
- Status last verified
- Oct 2026
- First submitted
- 26 Jul 2023
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results published in this report (after de-identification) (text, tables, figures).
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmenting Cognitive-behavioral Therapy With rTMS of the Medial Prefrontal and Anterior Cingulate Cortices for the Treatment of Cocaine Use Disorder
- ClinicalTrials.gov ID
- NCT05974202
- Acronym / sponsor ID
- COAST / 8483/Pro00076502
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Columbia University
- Study start
- 14 Aug 2026 (actual)
- Primary completion
- 28 Apr 2028 (estimated)
- Study completion
- 28 Apr 2028 (estimated)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Active high-frequency stimulation vs. sham (placebo) stimulation
| Arm | Type | Receives |
|---|---|---|
| Active iTBS rTMS | Active comparator | Device: Active H7-coil repetitive transcranial magnetic stimulation (rTMS)Daily repetitive transcranial magnetic brain stimulation for 1 week (20 sessions). |
| Sham (placebo) rTMS | Placebo comparator | Device: Sham H7-coil repetitive transcranial magnetic stimulation (rTMS)Sham rTMS uses the same device and mimics the auditory and scalp sensations without stimulating the brain. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 6 days in the past 28 days;
- 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
Key exclusion criteria (24 listed)
- Meets DSM-5 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);
- Hamilton Depression Rating Scale score > 17;
- Young Mania Rating Scale score >10;
- 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);
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active 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. | Device | Active iTBS rTMS |
| Sham 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. | Device | Sham (placebo) rTMS |
Primary outcome
Percentage of participants receiving at least 15 out of 20 rTMS sessions
Time frame: 1 week
Feasibility will be measured as the total percentage of participants who receive the defined number of rTMS sessions
Number of participants experiencing an rTMS-emergent serious adverse event
Time frame: 1 week
Safety of rTMS will be measured by the absolute number of serious adverse events that occur in the active rTMS arm
Number of participants with 15% decrease in RSFC (resting state functional connectivity) between the DLPFC (dorsolateral prefrontal cortex) and anterior cingulate.
Time frame: 1 week
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
Percentage of participants who achieve 3 weeks of abstinence during the final 12 weeks of the trial
Time frame: 12 weeks
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results published in this report (after de-identification) (text, tables, figures).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John Mariani, MD principal investigator
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active H7-coil repetitive transcranial magnetic stimulation (rTMS) in people with Cocaine Use and Cocaine Dependence, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Brooks, LCSW (646-774-8181, daniel.brooks@nyspi.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants receiving at least 15 out of 20 rTMS sessions (time frame: 1 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.