An interventional study of sTMS and sham sTMS in Cocaine Addiction, Opioid Addiction and Alcohol Addiction, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-01-17.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Other
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.
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.
2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.
This study's enrollment of 42 is below the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
current or prior neurologic disorder or lifetime history of
unstable medical condition,
active sTMS
Device: sTMS
sham sTMS
Device: sham sTMS
sTMS will be delivered following NeoSync guidelines using the device user manual
sham sTMS will be delivered following NeoSync guidelines using the device user manual
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.
Time frame: 6 weeks
substance specific craving
self reported reactivity to associated cues with 8 items ranked 1-7--higher scores indicating greater craving/urges
Time frame: 6 weeks
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.
Time frame: 6 weeks
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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VA Office of Research and Development