VA-StARTS: Treating Stimulant Addiction With Repetitive Transcranial Magnetic Stimulation

Sponsor

VA Office of Research and Development (U.S. Fed)

Overall Status

Recruiting

CT.gov ID

NCT04228276

Collaborator

Stanford University (Other)

Enrollment

Location

Arms

38.8

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stimulant Use Disorder Substance-related Disorders	Device: Repetitive transcranial magnetic stimulation (rTMS)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants will be randomly assigned to one of two groups to receive active or sham rTMS.Participants will be randomly assigned to one of two groups to receive active or sham rTMS.

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Treating Stimulant Addiction With Repetitive Transcranial Magnetic Stimulation

Actual Study Start Date :

Feb 5, 2021

Anticipated Primary Completion Date :

Apr 30, 2023

Anticipated Study Completion Date :

Apr 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active rTMS Receive active rTMS	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.
Sham Comparator: Sham rTMS Receive sham rTMS	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.

Arm

Intervention/Treatment

Experimental: Active rTMS

Receive active rTMS

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.

Sham Comparator: Sham rTMS

Receive sham rTMS

Device: Repetitive transcranial magnetic stimulation (rTMS)

Outcome Measures

Primary Outcome Measures

Relapse rate [3 months after last rTMS treatment]
Rate of stimulant use relapse and duration of abstinence compared between active vs. sham rTMS groups

Secondary Outcome Measures

Occupational/role functioning [Within 1 week before rTMS treatment, midpoint during rTMS treatment, within 1 week after rTMS treatment, and 3 months following rTMS treatment]
Occupational/role functioning and changes in functioning compared between active vs. sham rTMS groups
Rest/activity cycles [During 2-week rTMS treatment and for 1 month following treatment]
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.
Reward circuit function and signaling [Within 1 week before and after rTMS treatment]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Palo Alto Health Care System, Palo Alto, CA	Palo Alto	California	United States	94304-1290

Sponsors and Collaborators

VA Office of Research and Development
Stanford University

Investigators

Principal Investigator: Jong H. Yoon, MD, VA Palo Alto Health Care System, Palo Alto, CA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

VA Office of Research and Development

ClinicalTrials.gov Identifier:

NCT04228276

Other Study ID Numbers:

D3314-P
54458

First Posted:

Jan 14, 2020

Last Update Posted:

Mar 9, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by VA Office of Research and Development

Magnetic resonance imaging

Transcranial magnetic stimulation

Dopamine

Reward processing

Additional relevant MeSH terms:

Disease

Substance-Related Disorders

Study Results

No Results Posted as of Mar 9, 2022