rTMS for Stimulant Use Disorders

NCT ID: NCT04907357

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-04
• Study Completion Date: 2024-06-07

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.

Detailed Description

The study will be a randomized, double-blind, sham-controlled trial comparing rTMS vs. placebo delivered over an 8-week treatment period. After assessment and inclusion into the study, participants will be randomized to receive up to 30 sessions of either rTMS or placebo treatments. The target minimum number of rTMS/placebo treatments is 20 treatments over 8 weeks. The secondary objective is to gather preliminary data on the efficacy of rTMS for individuals with moderate to severe CUD or MUD. Follow-up visits occur at end of treatment and at 12- and 16-weeks following randomization.

Other study procedures:

Actigraphy: To assess daily sleep quality during weeks 1-8, the ActiGraph wristband device will record, sleep latency, sleep duration, and intervals of waking during the sleep period.

Electroencephalography (EEG): EEG will be obtained after randomization and again at week 4, to explore the potential for EEG to be used as a biomarker of treatment response.

Cognitive-Behavioral Educational Intervention: Participants in both conditions (rTMS and placebo) will be encouraged to participate in a mobile app-based educational intervention based on principles of Cognitive Behavioral Therapy (CBT) for Substance Use Disorder (SUD).

Daily Assessments: Brief, electronic remote surveys will be administered to participants daily until week 16 follow-up time point and will assess use of primary substance of abuse, craving, ability to resist use, overall mood, and self-rated sleep quality.

Urine Drug Screens (UDS): UDS will be collected at screening, randomization, every treatment session, and at follow-up visits.

Urine pregnancy tests: Pregnancy testing for all female participants will be performed at screening, randomization, and monthly during the treatment period.

Physical exam: A physical exam will be performed at screening.

Questionnaires: A battery of study assessments will be completed to further inform findings regarding feasibility and effects of rTMS on individuals with stimulant use disorders.

Conditions

Cocaine Use Disorder; Methamphetamine Abuse; Cocaine Dependence; Methamphetamine Dependence; Stimulant Use; Stimulant Abuse; Methamphetamine Use Disorder; Cocaine Abuse; Stimulant Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

rTMS

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

Group Type: ACTIVE_COMPARATOR

rTMS

Intervention Type: 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).

Sham (Placebo)

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

Group Type: SHAM_COMPARATOR

Sham (Placebo)

Intervention Type: 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).

Interventions

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).

Intervention Type: 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).

Intervention Type: DEVICE

Other Intervention Names

Repetitive Transcranial Magnetic Stimulation; TMS; Sham Repetitive Transcranial Magnetic Stimulation

Eligibility Criteria

Inclusion Criteria

• 18-65, 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Kathleen Brady

Distinguished University Professor, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathleen T Brady, MD PHD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Madhukar Trivedi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas South Western

Locations

Wake Forest

Winston-Salem, North Carolina, United States

Medical University of South Carolina

Charleston, South Carolina, United States

University of Texas Southwestern

Dallas, Texas, United States

University of Texas Health Science Center San Antonio

San Antonio, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40336040 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

UG1DA013727

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00107688

Identifier Type: -

Identifier Source: org_study_id