sTMS for Substance Use-disordered Veterans
Primary Purpose
Cocaine Addiction, Opioid Addiction, Alcohol Addiction
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
sTMS
sham sTMS
Sponsored by
About this trial
This is an interventional other trial for Cocaine Addiction focused on measuring Transcranial Magnetic Stimulation
Eligibility 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.
Sites / Locations
- Providence VA Medical Center, Providence, RI
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
active
sham
Arm Description
active sTMS
sham sTMS
Outcomes
Primary Outcome Measures
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.
substance specific craving
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)
The SOFAS is a global rating of current functioning ranging from 0 to 100, with lower scores representing lower functioning.
Secondary Outcome Measures
Full Information
NCT ID
NCT04336293
First Posted
March 20, 2020
Last Updated
October 17, 2023
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT04336293
Brief Title
sTMS for Substance Use-disordered Veterans
Official Title
sTMS for Substance Use-disordered Veterans
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 7, 2021 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 29, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Addiction, Opioid Addiction, Alcohol Addiction
Keywords
Transcranial Magnetic Stimulation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
double blind, sham controlled RCT
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double-blind
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
active
Arm Type
Experimental
Arm Description
active sTMS
Arm Title
sham
Arm Type
Sham Comparator
Arm Description
sham sTMS
Intervention Type
Device
Intervention Name(s)
sTMS
Intervention Description
sTMS will be delivered following NeoSync guidelines using the device user
manual
Intervention Type
Device
Intervention Name(s)
sham sTMS
Intervention Description
sham sTMS will be delivered following NeoSync guidelines using the device user manual
Primary Outcome Measure Information:
Title
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF)
Description
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.
Time Frame
6 weeks
Title
substance specific craving
Description
self reported reactivity to associated cues with 8 items ranked 1-7--higher scores indicating greater craving/urges
Time Frame
6 weeks
Title
Social and Occupational Functioning Assessment Scale (SOFAS)
Description
The SOFAS is a global rating of current functioning ranging from 0 to 100, with lower scores representing lower functioning.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John E McGeary, PhD
Organizational Affiliation
Providence VA Medical Center, Providence, RI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Providence VA Medical Center, Providence, RI
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908-4734
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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sTMS for Substance Use-disordered Veterans
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