sTMS for Substance Use-disordered Veterans

Sponsor

VA Office of Research and Development (U.S. Fed)

Overall Status

Recruiting

CT.gov ID

NCT04336293

Collaborator

(none)

Enrollment

Location

Arms

27.7

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cocaine Addiction Opioid Addiction Alcohol Addiction	Device: sTMS Device: sham sTMS	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

double blind, sham controlled RCTdouble 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 :

Sep 7, 2021

Anticipated Primary Completion Date :

Oct 31, 2023

Anticipated Study Completion Date :

Dec 29, 2023

Arms and Interventions

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

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

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Providence VA Medical Center, Providence, RI	Providence	Rhode Island	United States	02908

Sponsors and Collaborators

VA Office of Research and Development

Investigators

Principal Investigator: John E McGeary, PhD, Providence VA Medical Center, Providence, RI

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

VA Office of Research and Development

ClinicalTrials.gov Identifier:

NCT04336293

Other Study ID Numbers:

D3338-P
RX003338

First Posted:

Apr 7, 2020

Last Update Posted:

Aug 22, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by VA Office of Research and Development

Transcranial Magnetic Stimulation

Additional relevant MeSH terms:

Substance-Related Disorders

Cocaine-Related Disorders

Opioid-Related Disorders

Alcoholism

Behavior, Addictive

Study Results

No Results Posted as of Aug 22, 2022