Purpose

Study offers TMS treatment for people who use cocaine or methamphetamine and want to reduce their use.

Category

IRB Number
STUDY00000138
NCT Number
NCT04907357
Sponsor
Medical University of South Carolina -



Study Contact

Principal Investigator
Melissa Martinez

Brandie Otten
210-567-8251
otten@uthscsa.edu

Tara Wright
210-450-3903
wrightt3@uthscsa.edu



Eligibility

Eligible Ages
18-65
Eligible Genders
Female, Male
Accepts Healthy Volunteers
No

Inclusion Criteria


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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This is a double-blind, sham-controlled study.
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)
Condition
  • Cocaine Use Disorder
  • Methamphetamine Abuse
  • Cocaine Dependence
  • Methamphetamine Dependence
  • Stimulant Use
  • Stimulant Abuse
  • Methamphetamine Use Disorder
  • Cocaine Abuse
  • Stimulant Use Disorder

    • Arm Groups

    ArmDescriptionIntervention
    Sham Comparator

    Sham (Placebo)

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

    Other names:

    • Sham Repetitive Transcranial Magnetic Stimulation

    • Active Comparator

    rTMS

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

    Other names:

    • Repetitive Transcranial Magnetic Stimulation
    • TMS

    •