rTMS for Stimulant Use Disorders

Summary

The purpose of the study is to determine feasibility of repetitive transcranial magnetic stimulation (rTMS) for individuals with moderate to severe cocaine or methamphetamine use disorder (CUD/MUD). Potential participants will be age 18-65, and interested in cutting down or stopping use. Participants will be randomized to one of two groups; groups will receive rTMS or sham rTMS (placebo) over the course of an 8-week treatment period, and complete follow-up assessments at the end of treatment, 12, and 16 weeks post-randomization.

Conditions

• Cocaine Use Disorder
• Methamphetamine Abuse
• Cocaine Dependence
• Methamphetamine Dependence
• Stimulant Use
• Stimulant Abuse
• Methamphetamine Use Disorder
• Cocaine Abuse
• Stimulant Use Disorder

Interventions

DEVICE

rTMS

Each rTMS session will consist of 75 rTMS trains of 10 Hz for 4 seconds (40 pulses per train) with inter-train interval (ITI) of 11 seconds (a total of 3000 stimuli per session) over the left dorsolateral prefrontal cortex (DLPFC).

DEVICE

Sham (Placebo)

Each sham rTMS session will consist of 75 rTMS trains of 10 Hz for 4 seconds (40 pulses per train) with inter-train interval (ITI) of 11 seconds (a total of 3000 stimuli per session) over the left dorsolateral prefrontal cortex (DLPFC). In the placebo condition the magnetic field will be delivered in the opposite direction (away from the brain).

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Medical University of South Carolina

  lead OTHER

Principal Investigators

• Kathleen T Brady, MD PHD · Medical University of South Carolina

• Madhukar Trivedi, MD · University of Texas South Western

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-02-04

Primary Completion

2024-04-05

Completion

2024-06-07

FDA Device

Yes

Countries

• United States

Study Locations