Low Intensity Focused Ultrasound for Tobacco Use Disorder: High Resolution Targeting of the Human Insula (NCT06405074)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Veterans Affairs Medical Center — Washington D.C., District of Columbia
Age range: 18 Years to 75 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Veterans Affairs Medical Center — Washington D.C., District of Columbia
📞 Contact the Study Coordinator
Phone: (202) 745-8000
Email: mary.lee3@va.gov
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Tobacco Use Disorder
- Nicotine Replacement Therapy Prescribing and Lung Cancer Screening in Hospitalized Patients — Charleston, South Carolina
- Abstinence Reinforcement Therapy for Veterans Who Smoke Tobacco and Are Experiencing Homelessness — Durham, North Carolina
- 5-HT2A Agonist Psilocybin in the Treatment of Tobacco Use Disorder — Birmingham, Alabama
- Smoking Cessation Behavioral Treatment Study — Columbia, Missouri
- Beta-Adrenergic Modulation of Drug Cue Reactivity — Tulsa, Oklahoma
- An fMRI Study of the Effects of Clavulanic Acid on Drug Addiction — Columbia, Missouri
Explore by condition: All Tobacco Use Disorder clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.