Status:
COMPLETED
sTMS for Substance Use-disordered Veterans
Lead Sponsor:
VA Office of Research and Development
Conditions:
Cocaine Addiction
Opioid Addiction
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The purpose of this study is to determine if synchronized transcranial magnetic stimulation is safe and tolerable in individuals with cocaine, opioid, or alcohol use disorders.
Detailed Description
All non-life-saving human research studies suspended by sponsor in response to COVID19 social distancing policies The goal of this proposal is to evaluate preliminary participant response to a pilot,...
Eligibility Criteria
Inclusion
- Eligible male and female Veterans
- between ages 18-70,
- Veterans who currently meet criteria for SUD, and, if applicable, have stable treatment regimen (i.e., medications and/or therapy) for at least 6 weeks prior to study procedures
- ongoing medications and psychotherapy will be allowed to continue unchanged during the study
- for safety, participants must also meet established criteria for MRI exposure, which is implemented as a conservative measure given the novel application of sTMS in this population
Exclusion
- pregnancy/lactation,
- history of moderate or severe traumatic brain injury,
- current or prior neurologic disorder or lifetime history of
- seizure disorder
- CNS tumors
- stroke
- cerebral aneurysm,
- unstable medical condition,
- active suicidality as assessed with the Columbia-Suicide Severity Rating Scale
- primary psychotic disorder.
Key Trial Info
Start Date :
September 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 29 2023
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04336293
Start Date
September 7 2021
End Date
December 29 2023
Last Update
January 17 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, United States, 02908-4734