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sTMS for Substance Use-disordered Veterans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04336293
Recruitment Status : Recruiting
First Posted : April 7, 2020
Last Update Posted : August 22, 2022
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cocaine Addiction Opioid Addiction Alcohol Addiction Device: sTMS Device: sham sTMS Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Official Title: sTMS for Substance Use-disordered Veterans
Actual Study Start Date : September 7, 2021
Estimated Primary Completion Date : October 31, 2023
Estimated Study Completion Date : December 29, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04336293


Contacts
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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

Locations
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United States, Rhode Island
Providence VA Medical Center, Providence, RI Recruiting
Providence, Rhode Island, United States, 02908
Contact: John E McGeary, PhD    401-273-7100 ext 3393    John.McGeary@va.gov   
Principal Investigator: John E McGeary, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: John E McGeary, PhD Providence VA Medical Center, Providence, RI
More Information
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04336293    
Other Study ID Numbers: D3338-P
RX003338 ( Other Grant/Funding Number: VA )
First Posted: April 7, 2020    Key Record Dates
Last Update Posted: August 22, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by VA Office of Research and Development:
Transcranial Magnetic Stimulation
Additional relevant MeSH terms:
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Substance-Related Disorders
Cocaine-Related Disorders
Opioid-Related Disorders
Alcoholism
Behavior, Addictive
Compulsive Behavior
 Impulsive Behavior
Chemically-Induced Disorders
Mental Disorders
Narcotic-Related Disorders
Alcohol-Related Disorders