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Clinical Trials/NCT04228276
NCT04228276
Terminated
Not Applicable

Treating Stimulant Addiction With Repetitive Transcranial Magnetic Stimulation

VA Office of Research and Development1 site in 1 country30 target enrollmentFebruary 5, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stimulant Use Disorder
Sponsor
VA Office of Research and Development
Enrollment
30
Locations
1
Primary Endpoint
Number of Participants Relapsed
Status
Terminated
Last Updated
8 months ago

Overview

Brief Summary

The purpose of this study is to establish a new treatment (repetitive transcranial stimulation (rTMS)) for Veterans with stimulant use disorder (SUD). Despite the large public health burden imposed by SUD, there is currently no FDA-approved or widely recognized effective somatic treatment. rTMS may be a promising treatment option for SUD. In this study, we will demonstrate the feasibility of applying rTMS to Veterans with SUD, examine the efficacy of rTMS in the treatment of SUD, and explore biomarkers that may guide patient selection for rTMS treatment and predict treatment response.

Registry
clinicaltrials.gov
Start Date
February 5, 2021
End Date
June 1, 2024
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Structured Clinical Interview for DSM Disorders (SCID) confirmed diagnosis of SUD, severe
  • Last use of stimulants \>1 and \<6 weeks
  • Stable medication regimen (no change in dose or agents between 2 weeks prior to the start of and throughout the treatment phase of the study)
  • Stable social environment and housing to enable regular attendance at clinic visits.
  • Ability to undergo cognitive testing, functional magnetic resonance imaging (fMRI) scans, and rTMS (no contraindications)
  • Intelligence Quotient (IQ) \> 80
  • Stable medical health
  • Veteran at Palo Alto VA's Addiction Treatment Services

Exclusion Criteria

  • Pregnant or lactating female
  • History of prior adverse reaction to TMS
  • On medications thought to significantly lower seizure threshold, e.g.:
  • clozapine
  • chlorpromazine
  • clomipramine
  • bupropion \> 400 mg/day
  • Use of direct dopaminergic antagonists or agonists
  • History of seizures or conditions known to substantially increase risk for seizures
  • Implants or medical devices incompatible with TMS

Outcomes

Primary Outcomes

Number of Participants Relapsed

Time Frame: 3 months after last rTMS treatment

Rate of stimulant use relapse compared between active vs. sham rTMS groups

Secondary Outcomes

  • Reward Circuit Function and Signaling(Within 1 week before and after rTMS treatment)

Study Sites (1)

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