Clinical trial NCT04336293: sTMS for Substance Use-disordered Veterans
Official title: sTMS for Substance Use-disordered Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cocaine Addiction
Opioid Addiction
Alcohol Addiction
Keywords: Transcranial Magnetic Stimulation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-04-07
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double blind, sham controlled RCT
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF)
timeFrame: 6 weeks
measure: substance specific craving
timeFrame: 6 weeks
measure: Social and Occupational Functioning Assessment Scale (SOFAS)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Providence VA Medical Center, Providence, RI
state: Rhode Island
Study officials:
affiliation: Providence VA Medical Center, Providence, RI
name: John E McGeary, PhD
role: PRINCIPAL_INVESTIGATOR
References: