Low Intensity Focused Ultrasound for Tobacco Use Disorder: High Resolution Targeting of the Human Insula

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Tobacco Use Disorder

In brief

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.

Key facts

Study ID: NCT06405074
Run by: Washington D.C. Veterans Affairs Medical Center
People needed: 44
Starts: 2022-04-01
Expected to finish: 2026-03-31
Last updated by the study team: 2024-11-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male and female veterans aged 18-75 years
Meet the Diagnostic and Statistical Manual, Fifth edition (DSM-5) criteria for current TUD (moderate to severe) as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.
Currently smoking > 10 cigarettes per day with no period of abstinence > 3 months in the last year
Current use of tobacco in last year is limited to cigarettes
Currently in Contemplation Stage of motivation for behavior change with respect to smoking as assessed by the University of Rhode Island Change Assessment Scale

You may not qualify if…

Not under current treatment for smoking cessation.
No history of head injury, seizures, neurologic disorders including cerebrovascular disease, multiple sclerosis, or neurodegenerative diseases or major medical illness
Current substance use disorder for a psychoactive substance (except nicotine)
DSM-5 psychiatric disorder requiring current treatment
Ferromagnetic implants or other contraindications for MRI
Taking any psychotropic medication such as antidepressants, anxiolytics and antipsychotics.
any medication other than psychotropic medications that is known to cross the blood brain barrier and achieve brain penetrance such that it will alter BOLD signal or lower seizure threshold, such as antibiotics, antihistamines or muscle relaxants.
currently pregnant or breast feeding

Where it is running

Veterans Affairs Medical Center — Washington D.C., District of Columbia, United States (enrolling)

Full record on ClinicalTrials.gov

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