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NCT05723588 · ClinicalTrials.gov registry record · Phase 2

Neuroimaging Correlates and Feasibility of Transcranial Magnetic Stimulation (TMS) to Improve Smoking Cessation Outcomes in Veterans With Comorbid PTSD

A Phase 2 study of Tobacco Use Disorder, sponsored by VA Office of Research and Development.

Recruiting
Registry status
Phase 2
Development phase
50
Enrollment target
1
Study location

NCT05723588 is a Phase 2 study of Tobacco Use Disorder that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 50 participants, below the 239-participant average among 70 other Tobacco Use Disorder trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05723588, a Phase 2 study of Tobacco Use Disorder, is actively recruiting participants, sponsored by VA Office of Research and Development.

RECRUITING
Registry status
Phase 2
Development phase
50 participants
Enrollment target
1
Study location

Study Summary

Tobacco use is the number one preventable cause of the death in the United States, and is high among US Veterans, and those who have experienced trauma are more likely to smoke. Despite the efficacy of current evidence-based treatments for smoking cessation, there is a critical need for alternative treatments. This project seeks to evaluate the feasibility and effectiveness of a smoking cessation treatment for Veterans with posttraumatic stress disorder (PTSD) who smoke. The treatment combines smoking cessation counseling, nicotine replacement therapy (e.g., nicotine gum), and repetitive transcranial magnetic stimulation (rTMS). rTMS is a noninvasive brain stimulation treatment that has been cleared by the Food and Drug Administration for smoking cessation in adults.

Conditions Studied

Interventions

  • DEVICE active repetitive transcranial magnetic stimulation
  • DEVICE sham repetitive transcranial magnetic stimulation
  • BEHAVIORAL cognitive behavioral therapy for smoking cessation
  • DRUG nicotine replacement therapy

Study Locations (1)

North Carolina

  • Durham VA Medical Center, Durham, NC - Durham

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2023-10-31
Est. Completion 2027-11-01
Phase Phase 2

Sponsor

VA Office of Research and Development

1,668 total trials

What the Registry Record Tells You About NCT05723588

The ClinicalTrials.gov registry entry for NCT05723588 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 50 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 (79% lower). The listed sponsor is VA Office of Research and Development, which has 1,668 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 4 interventions - of which active repetitive transcranial magnetic stimulation is the first listed.

NCT05723588 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT05723588 about?

NCT05723588 is a clinical study titled "Neuroimaging Correlates and Feasibility of Transcranial Magnetic Stimulation (TMS) to Improve Smoking Cessation Outcomes in Veterans With Comorbid PTSD". Tobacco use is the number one preventable cause of the death in the United States, and is high among US Veterans, and those who have experienced trauma are more likely to smoke. Despite the efficacy of current evidence-based treatments for smoking cessation, there is a critical need for alternative ...

What is the current status of trial NCT05723588?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2023-10-31. Estimated completion is 2027-11-01.

What conditions does trial NCT05723588 study?

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

What interventions are being tested in trial NCT05723588?

The interventions under investigation include: active repetitive transcranial magnetic stimulation (DEVICE), sham repetitive transcranial magnetic stimulation (DEVICE), cognitive behavioral therapy for smoking cessation (BEHAVIORAL), nicotine replacement therapy (DRUG).

Who is sponsoring clinical trial NCT05723588?

This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05723588 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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