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NCT06405074 · ClinicalTrials.gov registry record · NA

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

A NA study of Tobacco Use Disorder, sponsored by Washington D.C. Veterans Affairs Medical Center.

Recruiting
Registry status
NA
Development phase
44
Enrollment target
1
Study location

NCT06405074 is a NA study of Tobacco Use Disorder that is actively recruiting participants, run by Washington D.C. Veterans Affairs Medical Center. The registered enrollment target is 44 participants, below the 239-participant average among 70 other Tobacco Use Disorder trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06405074, a NA study of Tobacco Use Disorder, is actively recruiting participants, sponsored by Washington D.C. Veterans Affairs Medical Center.

RECRUITING
Registry status
NA
Development phase
44 participants
Enrollment target
1
Study location

Study 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 Studied

Interventions

  • DEVICE low intensity focused ultrasound (LIFU)

Study Locations (1)

District of Columbia

  • Veterans Affairs Medical Center - Washington D.C.

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2022-04-01
Est. Completion 2026-03-31
Phase NA

What the Registry Record Tells You About NCT06405074

The ClinicalTrials.gov registry entry for NCT06405074 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 239-participant average among 70 other Tobacco Use Disorder trials with a reported enrollment target (82% lower). The listed sponsor is Washington D.C. Veterans Affairs Medical Center, which has 8 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Tobacco Use Disorder appearing as the primary indexed condition, and to 1 intervention - of which low intensity focused ultrasound (LIFU) is the first listed.

NCT06405074 reports 1 study location spanning 1 distinct geographic area - top geographies include District of Columbia.

Frequently Asked Questions

What is clinical trial NCT06405074 about?

NCT06405074 is a clinical study titled "Low Intensity Focused Ultrasound for Tobacco Use Disorder: High Resolution Targeting of the Human Insula". 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...

What is the current status of trial NCT06405074?

This trial is currently recruiting. It is a NA study. The enrollment target is 44 participants. The study started on 2022-04-01. Estimated completion is 2026-03-31.

What conditions does trial NCT06405074 study?

This clinical trial studies the following conditions: Tobacco Use Disorder.

What interventions are being tested in trial NCT06405074?

The interventions under investigation include: low intensity focused ultrasound (LIFU) (DEVICE).

Who is sponsoring clinical trial NCT06405074?

This trial is sponsored by Washington D.C. Veterans Affairs Medical Center, which has 8 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06405074 being conducted?

This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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