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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04228276
Other study ID # D3314-P
Secondary ID 54458
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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