sTMS for Substance Use-disordered Veterans

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Addiction; Opioid Addiction; Cocaine Addiction
• Intervention / Treatment: Device: sTMS; Device: sham sTMS

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02908-4734
      • Providence VA Medical Center, Providence, RI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: active; active sTMS	Device: sTMS; sTMS will be delivered following NeoSync guidelines using the device user manual
Sham Comparator: sham; sham sTMS	Device: sham sTMS; sham sTMS will be delivered following NeoSync guidelines using the device user manual

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: John E McGeary, PhD, Providence VA Medical Center, Providence, RI

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2021
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): December 29, 2023

Study Registration Dates

• First Submitted: March 20, 2020
• First Submitted That Met QC Criteria: April 2, 2020
• First Posted (Actual): April 7, 2020

Study Record Updates

• Last Update Posted (Estimated): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Transcranial Magnetic Stimulation
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Narcotic-Related Disorders; Compulsive Behavior; Impulsive Behavior; Substance-Related Disorders; Alcoholism; Opioid-Related Disorders; Behavior, Addictive; Cocaine-Related Disorders
• Other Study ID Numbers: D3338-P; RX003338 (Other Grant/Funding Number: VA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No