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Treating Stimulant Addiction With Repetitive Transcranial Magnetic Stimulation (VA-StARTS)

Primary Purpose

Stimulant Use Disorder, Substance-related Disorders

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Repetitive transcranial magnetic stimulation (rTMS)

About this trial

This is an interventional treatment trial for Stimulant Use Disorder focused on measuring Magnetic resonance imaging, Transcranial magnetic stimulation, Dopamine, Reward processing

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

VA Palo Alto Health Care System, Palo Alto, CARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active rTMS

Sham rTMS

Arm Description

Receive active rTMS

Receive sham rTMS

Outcomes

Primary Outcome Measures

Relapse rate

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

Secondary Outcome Measures

Occupational/role functioning

Occupational/role functioning and changes in functioning compared between active vs. sham rTMS groups

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.

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

Full Information

NCT ID

NCT04228276

First Posted

January 7, 2020

Last Updated

January 25, 2023

Sponsor

VA Office of Research and Development

Collaborators

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT04228276

Brief Title

Treating Stimulant Addiction With Repetitive Transcranial Magnetic Stimulation

Acronym

VA-StARTS

Official Title

Treating Stimulant Addiction With Repetitive Transcranial Magnetic Stimulation

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 5, 2021 (Actual)

Primary Completion Date

April 30, 2024 (Anticipated)

Study Completion Date

April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VA Office of Research and Development

Collaborators

Stanford University

4. Oversight

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.

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stimulant Use Disorder, Substance-related Disorders

Keywords

Magnetic resonance imaging, Transcranial magnetic stimulation, Dopamine, Reward processing

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active rTMS

Arm Type

Experimental

Arm Description

Receive active rTMS

Arm Title

Sham rTMS

Arm Type

Sham Comparator

Arm Description

Receive sham rTMS

Intervention Type

Device

Intervention Name(s)

Repetitive transcranial magnetic stimulation (rTMS)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Relapse rate

Description

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

Time Frame

3 months after last rTMS treatment

Secondary Outcome Measure Information:

Title

Occupational/role functioning

Description

Occupational/role functioning and changes in functioning compared between active vs. sham rTMS groups

Time Frame

Within 1 week before rTMS treatment, midpoint during rTMS treatment, within 1 week after rTMS treatment, and 3 months following rTMS treatment

Title

Rest/activity cycles

Description

Time Frame

During 2-week rTMS treatment and for 1 month following treatment

Title

Reward circuit function and signaling

Description

Time Frame

Within 1 week before and after rTMS treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jong H Yoon, MD

Phone

(650) 493-5000

jhyoon1@stanford.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jong H. Yoon, MD

Organizational Affiliation

VA Palo Alto Health Care System, Palo Alto, CA

Official's Role

Principal Investigator

Facility Information:

Facility Name

VA Palo Alto Health Care System, Palo Alto, CA

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304-1207

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jong H Yoon, MD

Phone

650-493-5000

jhyoon1@stanford.edu

First Name & Middle Initial & Last Name & Degree

Jong H. Yoon, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Treating Stimulant Addiction With Repetitive Transcranial Magnetic Stimulation

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