Providence VA Medical Center, Providence, RI
Providence, Rhode Island, 02908-4734, United States
NCT Number: NCT04336293
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.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Providence, Rhode Island, 02908-4734, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
Time frame: 6 weeks
self reported reactivity to associated cues with 8 items ranked 1-7--higher scores indicating greater craving/urges
Time frame: 6 weeks
The SOFAS is a global rating of current functioning ranging from 0 to 100, with lower scores representing lower functioning.
VA Office of Research and Development
Fed
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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