Treating Stimulant Addiction With Repetitive Transcranial Magnetic Stimulation

Substance-related Disorders Clinical Trial

— VA-StARTS  

Official title:

Treating Stimulant Addiction With Repetitive Transcranial Magnetic Stimulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04228276
• Other study ID #: D3314-P
• Secondary ID: 54458
• Status: Recruiting
• Phase: N/A
• Start date: February 5, 2021
• Est. completion date: April 30, 2024

Study information

• Verified date: February 2024
• Source: VA Office of Research and Development
• Contact: Jong H Yoon, MD
• Phone: (650) 493-5000
• Email: jhyoon1[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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, 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

• 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

Related Conditions & MeSH terms

• Stimulant Use Disorder
• Substance-related Disorders

Intervention

Device:
• Repetitive transcranial magnetic stimulation (rTMS)
rTMS is a non-invasive procedure in which administering a transient magnetic field induces electrical currents in specific, targeted brain regions. The intervention (active and sham) will be administered in 8 sessions across 2 weeks. The brain region targeted is the dorsolateral prefrontal cortex.

Locations

Country	Name	City	State
United States	VA Palo Alto Health Care System, Palo Alto, CA	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse rate	Rate of stimulant use relapse and duration of abstinence compared between active vs. sham rTMS groups	3 months after last rTMS treatment
Secondary	Occupational/role functioning	Occupational/role functioning and changes in functioning compared between active vs. sham rTMS groups	Within 1 week before rTMS treatment, midpoint during rTMS treatment, within 1 week after rTMS treatment, and 3 months following rTMS treatment
Secondary	Rest/activity cycles	Actigraphy will be conducted to examine rest/activity cycles during and following rTMS treatment. Changes will be compared between active and sham rTMS groups, and correlated with improvements in SUD.	During 2-week rTMS treatment and for 1 month following treatment
Secondary	Reward circuit function and signaling	Before and after treatment, participants will undergo functional magnetic resonance imaging (fMRI) imaging while completing the Monetary Incentive Delay Task, a validated probe of reward processing circuit function and dysfunction. Signaling in the substantia nigra will be measured in an individual-subject, "native space" ROI approach as a marker of dopaminergic reward processing function, as well as in voxel-wise, whole-brain exploratory analyses. Changes in reward function and signaling will be compared between active vs. sham rTMS groups	Within 1 week before and after rTMS treatment