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Completed

NCT Number: NCT04336293

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, 02908-4734, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

sTMS

Device

sTMS will be delivered following NeoSync guidelines using the device user

manual

sham sTMS

Device

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

Primary outcomes

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

    Time frame: 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.

  2. substance specific craving

    Time frame: 6 weeks

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

  3. Social and Occupational Functioning Assessment Scale (SOFAS)

    Time frame: 6 weeks

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

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 7, 2020
Registry last updated
Jan 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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