rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder

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.

Conditions

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

Interventions

DEVICE

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

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.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Columbia University

  collaborator OTHER

• New York State Psychiatric Institute

  lead OTHER

Principal Investigators

• John Mariani, MD · New York State Psychiatric Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

22 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-01

Primary Completion

2028-04-28

Completion

2028-04-28

FDA Device

Yes

Countries

• United States

Study Locations