NCT04336293

sTMS for Substance Use-disordered Veterans

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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, 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.

Conditions

• Cocaine Addiction
• Opioid Addiction
• Alcohol Addiction

Interventions

Type	Name	Description
DEVICE	sTMS	sTMS will be delivered following NeoSync guidelines using the device user manual
DEVICE	sham sTMS	sham sTMS will be delivered following NeoSync guidelines using the device user manual

Timeline

• Start date: 2021-09-07
• Primary completion: 2023-10-31
• Completion: 2023-12-29
• First posted: 2020-04-07
• Last updated: 2024-01-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study