Recruiting

Low Intensity Focused Ultrasound

Sponsor:

Washington D.C. Veterans Affairs Medical Center

Code:

NCT06405074

Conditions

Tobacco Use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

low intensity focused ultrasound (LIFU)

Study Details

Brief summary:

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

Tobacco Use Disorder

Study ID

NCT06405074

Start date

Apr 1, 2022

Status verified date

Nov, 2024

Completion date

Mar 31, 2026

Anticipated

Primary completion date

Mar 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Male and female veterans aged 18-75 years
2. 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.
3. Currently smoking > 10 cigarettes per day with no period of abstinence > 3 months in the last year
4. Current use of tobacco in last year is limited to cigarettes
5. Currently in Contemplation Stage of motivation for behavior change with respect to smoking as assessed by the University of Rhode Island Change Assessment Scale

Exclusion Criteria:

1. Not under current treatment for smoking cessation.
2. No history of head injury, seizures, neurologic disorders including cerebrovascular disease, multiple sclerosis, or neurodegenerative diseases or major medical illness
3. Current substance use disorder for a psychoactive substance (except nicotine)
4. DSM-5 psychiatric disorder requiring current treatment
5. Ferromagnetic implants or other contraindications for MRI
6. Taking any psychotropic medication such as antidepressants, anxiolytics and antipsychotics.
7. 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.
8. currently pregnant or breast feeding

Study Design

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: LIFU/Sham

double-blind, sham-controlled, crossover study in N=44 individuals with Tobacco Use Disorder

other: Sham/LIFU

double-blind, sham-controlled, crossover study in N=44 individuals with Tobacco Use Disorder

Interventions

low intensity focused ultrasound (LIFU)

Low-intensity focused ultrasound (LIFU) provides an energy source with millimeter resolution that can be focused anywhere in the brain safely and effectively for non-invasive and transient neuromodulation. LIFU is an important advance and of great significance for brain-mapping efforts, diagnostics, and therapies in neuroscience and particularly promising for addiction therapy as it provides unprecedented non-surgical access to the brain regardless of depth.

Much lower intensities of focused ultrasound (LIFU) are used so that tissue damage does not occur, but neural activity can be modulated. LIFU utilizes acoustic energy at much lower levels to affect tissue by mechanical effects.

Primary outcome measure

  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: immediately prior to 1 session LIFU and within 1 hour post LIFU; immediately prior to 1 session sham and with in 1 hour post shamdays ]

Central Contacts and Locations

Central contacts

Mary R. Lee, MD

202-745-8000mary.lee3@va.gov

Evan Lindeman, BS

evan.lindeman@va.gov

Locations

Veterans Affairs Medical Center

Recruiting

Washington, District of Columbia, United States, 20422

More Information

Sponsor

Washington D.C. Veterans Affairs Medical Center

Last update posted

Nov 20, 2024

Last verified

Nov, 2024

Keywords

  • low intensity focused ultrasound
  • functional magnetic resonance imaging
  • insula

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Washington D.C. Veterans Affairs Medical Center on 2024-11-20.