sTMS for Substance Use-disordered Veterans

• ClinicalTrials.gov Identifier: NCT04336293
• Recruitment Status: Completed
• First Posted: April 7, 2020
• Last Update Posted: January 17, 2024
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

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	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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 42 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
• Actual Primary Completion Date: October 31, 2023
• Actual Study Completion Date: December 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

Outcome Measures

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

• 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

Locations

United States, Rhode Island

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, United States, 02908-4734

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)

Documents provided by VA Office of Research and Development:

Informed Consent Form  [PDF] August 2, 2023

More Information

• 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
• Last Update Posted: January 17, 2024
• Last Verified: January 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

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