rTMS for Stimulant Use Disorders

NCT04907357 | Completed Results DMC FDA Device

• 2 other identifiers: 00107688UG1DA013727
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Stimulant; Cocaine; Methamphetamine; Repetitive Transcranial Magnetic Stimulation; rTMS

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Receive at Least 20 Sessions of rTMS/Sham Over the Treatment Period.

  Treatment session attendance and completion will be tracked over the course of the study, and this record will constitute the primary feasibility outcome.

  From first treatment session (Week 1, first study visit) to end of treatment at 8 weeks

Secondary Outcomes (1)

• Negative UDS From Weekly UDS

  From first treatment week (Week 1) to end of treatment at 8 weeks

Study Arms (2)

rTMS

ACTIVE COMPARATOR

Participants will receive up to 30 rTMS sessions within the 8-week treatment period.

Device: rTMS

Sham (Placebo)

SHAM COMPARATOR

Participants will receive up to 30 sham rTMS sessions within the 8-week treatment period.

Device: Sham (Placebo)

Interventions

rTMS DEVICE

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).

Also known as: Repetitive Transcranial Magnetic Stimulation, TMS

rTMS

Sham (Placebo) DEVICE

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).

Also known as: Sham Repetitive Transcranial Magnetic Stimulation

Sham (Placebo)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• , inclusive
• Have a diagnosis of moderate or severe Cocaine or Methamphetamine Use Disorder (CUD/MUD) over the past 12 months (as determined by DSM-5 diagnostic criteria).
• Have used cocaine or methamphetamine on at least 10 of the last 30 days (based on Timeline Follow-Back).
• Be interested in decreasing cocaine and/or methamphetamine use.
• If female, willing to use appropriate birth control method during the treatment phase of the study.
• Be able to understand the study procedures and provide written informed consent to participate in the study.
• If prescribed benzodiazepines or anticonvulsants, must be on a stable dose for at least 4 weeks prior to consent.

You may not qualify if:

• A Diagnostic and Statistical Manual (DSM-5) diagnosis of moderate or severe SUD of any substance other than cocaine or methamphetamine based on DSM-5.
• History of a serious medical disorder that, in the opinion of the Medical Clinician, would make it unsafe to participate in the study or may prevent collection of study data.
• Is currently engaged in formal SUD treatment.
• Documented history of unprovoked seizure (lifetime) or any seizure in the past 6 months.
• Documented history of brain lesion(s) and/or tumor(s).
• Metal implants or non-removable metal objects above the waist.
• Currently pregnant.
• Lifetime history of prior clinical treatment with TMS.
• Current or lifetime bipolar disorder.
• Current psychotic disorder or psychotic depression.
• Serious risk of homicide or suicide.
• Are a prisoner or in police custody at the time of eligibility screening.
• Previously randomized as a participant in the study.
• Planned admission to a residential treatment facility or other formal SUD treatment program.
• Unwilling or unable to follow study procedures.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (4)

Wake Forest

Winston-Salem, North Carolina, 27101, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

University of Texas Health Science Center San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Atoui Z, Egan D, Jha MK, Hartwell K, Toll R, Sonne S, Brunner-Jackson B, Subramaniam G, McCauley JL, Trivedi M, Brady K. Repetitive transcranial magnetic stimulation for stimulant use disorders (STIMULUS): protocol for a multi-site, double-blind, randomized controlled trial. Addict Sci Clin Pract. 2025 May 8;20(1):40. doi: 10.1186/s13722-025-00567-w.

  PMID: 40336040 DERIVED

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Limitations and Caveats

Initial planned recruitment for the study was 160. An interim sample size re-estimation was completed and the targeted sample size was adjusted. A total of 129 individuals were randomized for participation.

Results Point of Contact

• Title: Kathleen Brady, MD, PhD
• Organization: Medical University of South Carolina

bradyk@musc.edu

843-792-5205

Study Officials

• Kathleen T Brady, MD PHD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Madhukar Trivedi, MD

  University of Texas South Western

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished University Professor, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina

Model Details: This is a double-blind, sham-controlled study.

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: May 28, 2021
• Study Start: February 4, 2022
• Primary Completion: April 5, 2024
• Study Completion: June 7, 2024
• Last Updated: July 3, 2025
• Results First Posted: February 20, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data sets for this protocol will be available after (1) the primary paper has been accepted for publication, or (2) the data is locked for more than 18 months, whichever comes first.
• Access Criteria: Prior to downloading any study data, the user will be prompted to complete a registration agreement for data use. Users will have to register a name and valid e-mail address in order to download data and to accept their responsibility for using data in accordance with the NIDA Data Share Agreement.

Locations

US (4)