sTMS for Substance Use-disordered Veterans

VA Office of Research and Development42 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Cocaine Addiction Opioid Addiction Alcohol Addiction

Interventions

sTMSDEVICE

sTMS will be delivered following NeoSync guidelines using the device user manual

sham sTMSDEVICE

sham sTMS will be delivered following NeoSync guidelines using the device user manual

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, United States

Outcomes

Primary Outcomes

Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF)

Quality of Life Enjoyment and Satisfaction Questionnaire The Q-LES-Q-SF evaluates general activities that are assessed in the longer form of the Q- LES-Q. Each item uses a 5-point scale ranging from 1 (very poor) to 5 (very good). A total score is derived from 14 items with a maximum score of 70 and with higher scores indicating greater life satisfaction and enjoyment.

Time frame: 6 weeks

substance specific craving

self reported reactivity to associated cues with 8 items ranked 1-7--higher scores indicating greater craving/urges

Time frame: 6 weeks

Social and Occupational Functioning Assessment Scale (SOFAS)

The SOFAS is a global rating of current functioning ranging from 0 to 100, with lower scores representing lower functioning.

Time frame: 6 weeks

Data from ClinicalTrials.gov

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