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sTMS for Substance Use-disordered Veterans

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ClinicalTrials.gov Identifier: NCT04336293
Recruitment Status : Recruiting
First Posted : April 7, 2020
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE March 20, 2020
First Posted Date  ICMJE April 7, 2020
Last Update Posted Date September 16, 2021
Actual Study Start Date  ICMJE September 7, 2021
Estimated Primary Completion Date October 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2020)
  • 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.
  • 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
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 2, 2020)
  • quality of life [ 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.
  • 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
  • Social and Occupational Functioning Scale [ Time Frame: 6 weeks ]
    The SOFAS is a global rating of current functioning ranging from 0 to 100, with lower scores representing lower functioning.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE sTMS for Substance Use-disordered Veterans
Official Title  ICMJE sTMS for Substance Use-disordered Veterans
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
double blind, sham controlled RCT
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
double-blind
Primary Purpose: Other
Condition  ICMJE
  • Cocaine Addiction
  • Opioid Addiction
  • Alcohol Addiction
Intervention  ICMJE
  • Device: sTMS

    sTMS will be delivered following NeoSync guidelines using the device user

    manual

  • Device: sham sTMS
    sham sTMS will be delivered following NeoSync guidelines using the device user manual
Study Arms  ICMJE
  • Experimental: active
    active sTMS
    Intervention: Device: sTMS
  • Sham Comparator: sham
    sham sTMS
    Intervention: Device: sham sTMS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 2, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2022
Estimated Primary Completion Date October 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: John E McGeary, PhD (401) 273-7100 ext 3393 John.McGeary@va.gov
Contact: Noah S Philip, MD (401) 273-7100 ext 6200 noah.philip@va.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04336293
Other Study ID Numbers  ICMJE D3338-P
RX003338 ( Other Grant/Funding Number: VA )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John E McGeary, PhD Providence VA Medical Center, Providence, RI
PRS Account VA Office of Research and Development
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP