sTMS for Substance Use-disordered Veterans

VA Office of Research and Development

Status

Completed

Conditions

Opioid Addiction

Cocaine Addiction

Alcohol Addiction

Treatments

Device: sham sTMS

Device: sTMS

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT04336293

RX003338 (Other Grant/Funding Number)

D3338-P

Details and patient eligibility

About

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.

Full 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, controlled, feasibility study to evaluate changes in craving, substance use, and quality of life after 6 weeks of a low-risk non-invasive brain stimulation technique, called Synchronized Transcranial Magnetic Stimulation (sTMS), compared to sham, in Veterans with a substance use disorder (SUD). An important focus of this application will be evaluating the acceptability, tolerability, and safety of sTMS in this population. To the investigators knowledge, sTMS has never been used for SUDs, and holds considerable promise as a future treatment option for these prevalent disorders. However initial work in the acceptability, tolerability, and safety of this approach must be conducted first. This project is the first step towards the investigators long-term goal, which is to combine non-invasive brain stimulation with individualized psychotherapy or pharmacotherapy to reduce SUD problems and improve quality of life for Veterans.

Enrollment

42 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.