sTMS for Substance Use-disordered Veterans

Not Applicable

Completed

• Conditions: Cocaine Addiction; Opioid Addiction; Alcohol Addiction
• Interventions: Device: sham sTMS; Device: sTMS

• Registration Number: NCT04336293
• Lead Sponsor: VA Office of Research and Development

Brief 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.

Study Timeline

• Study First Submitted: 2020-03-20
• Study First Submitted QC: 2020-04-02
• Study First Posted: 2020-04-07
• Study Start: 2021-09-07
• Primary Completion: 2023-10-31
• Study Completion: 2023-12-29
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-12
• Last Update Posted: 2024-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham	sham sTMS	sham sTMS
active	sTMS	active sTMS

Primary Outcome Measures

Name	Time	Method
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF)	6 weeks	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.
substance specific craving	6 weeks	self reported reactivity to associated cues with 8 items ranked 1-7--higher scores indicating greater craving/urges
Social and Occupational Functioning Assessment Scale (SOFAS)	6 weeks	The SOFAS is a global rating of current functioning ranging from 0 to 100, with lower scores representing lower functioning.

Trial Locations

Locations (1)

Providence VA Medical Center, Providence, RI; 🇺🇸 Providence, Rhode Island, United States