Treating Stimulant Addiction With Repetitive Transcranial Magnetic Stimulation

  • STATUS
    Recruiting
  • End date
    Feb 5, 2024
  • participants needed
    48
  • sponsor
    VA Office of Research and Development
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Updated on 17 February 2021
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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.

Details
Condition Drug abuse, Substance Abuse, Drug use, Stimulant Use Disorder, Substance Abuse, Drug use
Treatment Repetitive Transcranial Magnetic Stimulation (rTMS)
Clinical Study IdentifierNCT04228276
SponsorVA Office of Research and Development
Last Modified on17 February 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

SCID confirmed diagnosis of SUD, severe
Last use of stimulants >2 and <4 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, fMRI scans, and rTMS (no contraindications)
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
Opioid replacement therapy
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
Acute or unstable chronic medical illness that would affect participation or compliance with study procedures, e.g. unstable angina
Unstable psychiatric symptoms that precludes consistent participation in the study, e.g
active current suicidal intent or plan
severe psychosis
Inability to undergo fMRI scan, e.g. claustrophobia, presence of ferromagnetic objects in subject's body
Other substance use disorder not in sustained remission
Chronic or recurring Axis I psychiatric condition preceding SUD other than PTSD
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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