Clinical trial NCT04228276: Treating Stimulant Addiction With Repetitive Transcranial Magnetic Stimulation
Official title: Treating Stimulant Addiction With Repetitive Transcranial Magnetic Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stimulant Use Disorder
Substance-related Disorders
Keywords: Magnetic resonance imaging
Transcranial magnetic stimulation
Dopamine
Reward processing
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Stanford University
First posted: 2020-01-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of two groups to receive active or sham rTMS.
Primary purpose: TREATMENT

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.


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
* 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

Primary outcomes:
measure: Number of Participants Relapsed
timeFrame: 3 months after last rTMS treatment
Secondary outcomes:
measure: Reward Circuit Function and Signaling
timeFrame: Within 1 week before and after rTMS treatment
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System, Palo Alto, CA
state: California
Study officials:
affiliation: VA Palo Alto Health Care System, Palo Alto, CA
name: Jong H. Yoon, MD
role: PRINCIPAL_INVESTIGATOR
References: