rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder

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.

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

2026-08-14

Primary Completion

2028-04-28

Completion

2028-04-28

FDA Device

Yes

Countries

• United States

Study Locations