Actively Recruiting
Low Intensity Focused Ultrasound for Tobacco Use Disorder: High Resolution Targeting of the Human Insula
Led by Washington D.C. Veterans Affairs Medical Center · Updated on 2024-11-20
44
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to to inhibit the dorsal anterior insula (dAI) with low intensity focused ultrasound (LIFU) to determine the causal role for the dAI in smoking cue induced craving in individuals with tobacco use disorder (TUD); smoking cue induced craving is a clinically important behavior which has been associated with the severity of nicotine addiction. The main question\[s\] it aims to answer are: * the safety and tolerability of dAI LIFU compared to sham stimulation in individuals with TUD * the effects of LIFU vs sham to left dAI functional magnetic resonance imaging (fMRI) BOLD activity and craving in response to smoking cue exposure. Participants will undergo anatomical MRI, neurological assessment, clinical assessment and patient query to assess the safety and tolerability of LIFU vs sham. Participants will undergo functional magnetic resonance imaging where we will measure the effect of LIFU vs sham on 1) dAI blood-oxygen-level-dependent (BOLD) activation in response to smoking (compared to neutral) cue exposure and 2) cue-induced craving in individuals with TUD. Each participant will receive LIFU and sham stimulation.
CONDITIONS
Official Title
Low Intensity Focused Ultrasound for Tobacco Use Disorder: High Resolution Targeting of the Human Insula
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female veterans aged 18-75 years
- Diagnosis of moderate to severe tobacco use disorder according to DSM-5 criteria
- Currently smoking more than 10 cigarettes per day with no abstinence longer than 3 months in the past year
- Tobacco use in the past year limited to cigarettes only
- Currently in the Contemplation Stage of motivation to change smoking behavior as assessed by a standardized scale
You will not qualify if you...
- Not currently receiving treatment for smoking cessation
- History of head injury, seizures, neurologic disorders including cerebrovascular disease, multiple sclerosis, neurodegenerative diseases, or major medical illness
- Current substance use disorder for psychoactive substances other than nicotine
- Psychiatric disorders requiring current treatment
- Presence of ferromagnetic implants or other contraindications for MRI
- Use of psychotropic medications such as antidepressants, anxiolytics, or antipsychotics
- Use of medications known to cross the blood brain barrier that could alter brain activity or lower seizure threshold
- Currently pregnant or breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
Veterans Affairs Medical Center
Washington D.C., District of Columbia, United States, 20422
Actively Recruiting
Research Team
M
Mary R. Lee, MD
CONTACT
E
Evan Lindeman, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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