rTMS and Cognitive-Behavioral Therapy for Cocaine Use Disorder

Overseen By Elizabeth Martinez

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: New York State Psychiatric Institute

Must not be taking: Antipsychotics, Lithium, Tricyclics, others

Disqualifiers: Depression, Bipolar, Schizophrenia, others

Compensation: Varies

Number of Visits: 27

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist individuals with cocaine use disorder. It tests whether adding repetitive transcranial magnetic stimulation (rTMS)—a non-invasive brain procedure—to standard cognitive-behavioral therapy (CBT) can aid in stopping cocaine use. The trial also examines how rTMS affects the brain and its safety as an addition to CBT. Individuals who have used cocaine at least weekly for the past month and are seeking treatment may qualify for this study. Participants will undergo brain scans, receive 3 weeks of active H7-coil rTMS or a placebo treatment, and attend 12 weeks of weekly CBT sessions.

As an unphased trial, this study allows participants to contribute to innovative research that could lead to new treatment options for cocaine use disorder.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it excludes those taking medications that lower the seizure threshold or are ototoxic. It's best to discuss your specific medications with the trial team.

What prior data suggests that rTMS is safe for treating cocaine use disorder?

Research shows that repetitive transcranial magnetic stimulation (rTMS) is generally safe when patients undergo proper health screenings to identify any risks. In past studies, researchers used rTMS in approved ways, and participants tolerated it well.

For individuals with cocaine use disorder, rTMS has shown potential in reducing cravings, which could aid in treatment. Although the FDA has not yet approved this treatment specifically for this condition, it has been tested in similar situations with good safety results. Participants in these studies did not report any major side effects when the treatment was used correctly. This suggests that rTMS could be a safe option for those considering joining this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using repetitive transcranial magnetic stimulation (rTMS) for cocaine use disorder because it offers a non-invasive, brain-focused approach to treatment. Unlike traditional methods such as behavioral therapies or medications like disulfiram, rTMS directly targets brain regions involved in addiction, potentially reducing cravings and relapse risk. This treatment involves high-frequency magnetic pulses, which can modulate brain activity without the need for drugs, making it appealing for those seeking alternative therapies. Additionally, the sham version of rTMS mimics the experience without actual stimulation, allowing researchers to better understand the treatment's true effectiveness.

What evidence suggests that this trial's treatments could be effective for cocaine use disorder?

Research shows that repetitive transcranial magnetic stimulation (rTMS) using the H7 coil has had early success in reducing the urge to seek cocaine. In this trial, participants will receive either active high-frequency rTMS or sham (placebo) rTMS. Studies have found that active rTMS can help lower both cocaine use and the chances of relapsing, as confirmed by lab tests and personal reports. This treatment uses magnetic fields to stimulate brain areas linked to addiction, potentially enhancing the effects of cognitive-behavioral therapy (CBT). While medications for cocaine addiction haven't always worked well, rTMS offers a promising new approach. This technique is considered practical and may provide new hope for those looking to cut down on cocaine use. ^{1 4 6 7 8}

Who Is on the Research Team?

John Mariani, MD

Principal Investigator

New York State Psychiatric Institute

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with moderate to severe cocaine use disorder who are seeking treatment. They must have used cocaine on at least 9 days in the last month and agree to limit alcohol intake and avoid certain drugs. Women must use effective contraception.

Inclusion Criteria

You are capable of providing informed consent and adhering to study protocols.

You fulfill the diagnostic criteria for current moderate to severe Cannabis Use Disorder as specified in the DSM-5 and are seeking treatment.

Age 18-65;

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

rTMS Treatment

Participants undergo 3 weeks of daily rTMS (or sham) treatments (15 sessions) targeting the mPFC/dACC

3 weeks

15 visits (in-person)

Cognitive-behavioral Therapy

Participants receive 12 weeks of once-weekly cognitive-behavioral therapy for the treatment of cocaine use disorder

12 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Active H7-coil repetitive transcranial magnetic stimulation (rTMS)
• Sham H7-coil repetitive transcranial magnetic stimulation (rTMS)

Trial Overview The study compares active rTMS, a non-invasive brain stimulation technique, with sham (placebo) rTMS before cognitive-behavioral therapy sessions for treating cocaine addiction. It explores safety, feasibility, brain mechanisms of rTMS, and its effectiveness in aiding abstinence.

How Is the Trial Designed?

Group I: Active (high-frequency) rTMS Active Control 1 Intervention

Daily high-frequency (10 Hz) repetitive transcranial magnetic brain stimulation for 3 weeks (15 sessions).

Group II: Sham (placebo) rTMS Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

New York State Psychiatric Institute

Lead Sponsor

Trials

481

Recruited

154,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

Published Research Related to This Trial

Repetitive transcranial magnetic stimulation (rTMS) shows promise as a noninvasive treatment for substance use disorders (SUDs) like cocaine and opioid use disorders by inducing neuroplastic changes in the brain, which can help reduce cravings and drug use.

The field faces several 'known unknowns' that need to be addressed to optimize rTMS for SUDs, including selecting the right cortical targets, understanding subcortical circuit engagement, and determining the best treatment sequences, highlighting the need for collaborative research efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating cocaine and opioid use disorder with transcranial magnetic stimulation: A path forward. Steele, VR., Maxwell, AM.[2023]

In a study of 44 patients with cocaine use disorder, 5-Hz repetitive transcranial magnetic stimulation (rTMS) significantly reduced cravings and impulsivity over a 2-week treatment period, indicating its potential efficacy as an adjunctive therapy.

The treatment also led to increased functional connectivity in brain regions associated with decision-making and impulse control, with effects lasting for up to 3 months, although they diminished by 6 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and Functional Connectivity Outcomes of 5-Hz Repetitive Transcranial Magnetic Stimulation as an Add-on Treatment in Cocaine Use Disorder: A Double-Blind Randomized Controlled Trial. Garza-Villarreal, EA., Alcala-Lozano, R., Fernandez-Lozano, S., et al.[2022]

Repetitive Transcranial Magnetic Stimulation (rTMS) is generally safe and feasible for patients with neuropsychiatric disorders who also have a history of substance use, based on a review of 274 articles.

However, the impact of different levels of substance use on the safety and efficacy of rTMS remains unclear, indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing substance use in patients receiving therapeutic repetitive transcranial magnetic stimulation: A scoping review. Tang, VM., Ibrahim, C., Rodak, T., et al.[2023]

In a pilot study involving 18 participants with cocaine use disorder, high-frequency rTMS (10 Hz) significantly reduced cocaine-seeking behavior compared to baseline, indicating its potential as a treatment option.

No significant effects were observed in the low-frequency (1 Hz) or sham groups, suggesting that the efficacy of rTMS may depend on the frequency of stimulation applied to the prefrontal cortex.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Magnetic Stimulation of Medial Prefrontal and Cingulate Cortices Reduces Cocaine Self-Administration: A Pilot Study. Martinez, D., Urban, N., Grassetti, A., et al.[2022]

In a study of 284 outpatients with cocaine-use disorder, 3 months of repetitive transcranial magnetic stimulation (rTMS) led to significant long-lasting reductions in cocaine use, with a median time to first lapse of 91 days.

The treatment was well-tolerated, with infrequent serious adverse events, and the frequency of cocaine use dropped to less than one day per month for most patients, indicating rTMS could be a promising intervention for cocaine addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Outcome of Repetitive Transcranial Magnetic Stimulation in a Large Cohort of Patients With Cocaine-Use Disorder: An Observational Study. Madeo, G., Terraneo, A., Cardullo, S., et al.[2020]

Repetitive transcranial magnetic stimulation (rTMS) has shown effectiveness in reducing cravings for tobacco, alcohol, and cocaine when applied at high frequencies to the dorsolateral prefrontal cortex (DLPFC), based on a review of eight studies.

Repeated sessions of high-frequency rTMS over the DLPFC may be particularly beneficial for decreasing smoking and alcohol consumption, suggesting that rTMS could be a promising treatment option for drug addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation and drug addiction. Barr, MS., Farzan, F., Wing, VC., et al.[2019]

Repetitive transcranial magnetic stimulation (rTMS) shows promise as a non-invasive treatment for cocaine and methamphetamine use disorders by potentially inducing beneficial changes in brain circuits related to addiction, particularly affecting dopamine and glutamate systems.

Clinical studies indicate that rTMS can alter brain network connectivity, which may help reduce cravings in individuals with substance use disorders, suggesting a new avenue for effective treatment where no FDA-approved options currently exist.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

rTMS-Induced Changes in Glutamatergic and Dopaminergic Systems: Relevance to Cocaine and Methamphetamine Use Disorders. Moretti, J., Poh, EZ., Rodger, J.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8658408/

Transcranial Magnetic Stimulation for the Treatment of ... The primary effectiveness outcomes were the reduction of cocaine use or relapses, evaluated by laboratory analyses (e.g., urine, hair), self- and hetero report.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05974202?cond=%22Cocaine-Related%20Disorders%22&aggFilters=status:not%20rec&rank=4

rTMS and Cognitive-behavioral Therapy for Cocaine Use ... The goal of this clinical trial is to compare the effects of active repetitive transcranial magnetic stimulation (rTMS) to sham (placebo) rTMS prior to ...

3. reporter.nih.gov reporter.nih.gov/search/10EECF0E478CC3D57598B8961CAA4A01A2FFCEB861BF/project-details/10681981

Project Details - NIH RePORTER Medications for cocaine use disorder have not shown consistent results and none have received FDA approval. Repetitive transcranial magnetic stimulation (rTMS) ...

4. tandfonline.com tandfonline.com/doi/full/10.1080/17434440.2021.2013803

Deep TMS H7 Coil: Features, Applications & Future Here we assembled all peer-reviewed publications on the H7 Coil to showcase its efficacy in: (a) various OCD patient populations (e.g., different degrees of ...

5. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2018.00080/epub

rTMS for CUD Overall, these results show that rTMS using the H7 coil is feasible, and shows preliminary efficacy in decreasing cocaine-seeking behavior.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2451902225001259

Deep Transcranial Magnetic Stimulation Efficacy in ... Bilateral brain stimulation by H-coils provides a significant clinical advantage in addressing whole-brain disorders, such as addiction, ...

7. medrxiv.org medrxiv.org/content/10.1101/2025.10.02.25337151v1.full.pdf

Repetitive Transcranial Magnetic Stimulation in Substance ... rTMS is generally considered safe when participants are properly screened and rTMS is applied within approved therapeutic protocols in many ...

8. withpower.com withpower.com/trial/rtms-and-cognitive-behavioral-therapy-for-cocaine-use-disorder-62088

rTMS and Cognitive-Behavioral Therapy for Cocaine Use ... In a study of 44 patients with cocaine use disorder, 5-Hz repetitive transcranial magnetic stimulation (rTMS) significantly reduced cravings and impulsivity ...