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Status:

COMPLETED

rTMS for Stimulant Use Disorders

Lead Sponsor:

Medical University of South Carolina

Collaborating Sponsors:

National Institute on Drug Abuse (NIDA)

Conditions:

Cocaine Use Disorder

Methamphetamine Abuse

Eligibility:

All Genders

18-65 years

Phase:

NA

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). P...

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 wi...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

February 4 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 7 2024

Estimated Enrollment :

129 Patients enrolled

Trial Details

Trial ID

NCT04907357

Start Date

February 4 2022

End Date

June 7 2024

Last Update

July 3 2025

Active Locations (4)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (4 locations)

1

Wake Forest

Winston-Salem, North Carolina, United States, 27101

2

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

3

University of Texas Southwestern

Dallas, Texas, United States, 75390

4

University of Texas Health Science Center San Antonio

San Antonio, Texas, United States, 78229