sTMS for Substance Use-disordered Veterans

Cocaine Addiction Clinical Trial

Official title:

sTMS for Substance Use-disordered Veterans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04336293
• Other study ID #: D3338-P
• Secondary ID: RX003338
• Status: Completed
• Phase: N/A
• Start date: September 7, 2021
• Est. completion date: December 29, 2023

Study information

• Verified date: January 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 29, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Addiction
• Alcoholism
• Behavior, Addictive
• Cocaine Addiction
• Cocaine-Related Disorders
• Opioid Addiction
• Opioid-Related Disorders
• Substance-Related Disorders

Intervention

Device:
• sTMS
sTMS will be delivered following NeoSync guidelines using the device user manual
• sham sTMS
sham sTMS will be delivered following NeoSync guidelines using the device user manual

Locations

Country	Name	City	State
United States	Providence VA Medical Center, Providence, RI	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks
Primary	substance specific craving	self reported reactivity to associated cues with 8 items ranked 1-7--higher scores indicating greater craving/urges	6 weeks
Primary	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.	6 weeks