sTMS for Substance Use-disordered Veterans

Study Overview
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Brief Summary
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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
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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.

Official Title
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sTMS for Substance Use-disordered Veterans

Conditions
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Cocaine Addiction, Opioid Addiction, Alcohol Addiction

Intervention / Treatment
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* Device: sTMS
* Device: sham sTMS


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: double blind, sham controlled RCT
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: active<br>active sTMS | Device: sTMS<br>* sTMS will be delivered following NeoSync guidelines using the device user manual<br>|
| Sham Comparator: sham<br>sham sTMS | Device: sham sTMS<br>* sham sTMS will be delivered following NeoSync guidelines using the device user manual<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 weeks | 
| substance specific craving | self reported reactivity to associated cues with 8 items ranked 1-7--higher scores indicating greater craving/urges | 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. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcranial Magnetic Stimulation