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

NCT05723588 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-02-18

No results posted yet for this 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

  • Tobacco Use Disorder

Interventions

DEVICE

active repetitive transcranial magnetic stimulation

Active rTMS is a non-invasive brain stimulation intervention that is FDA cleared as a treatment for smoking cessation in adults.

DEVICE

sham repetitive transcranial magnetic stimulation

Sham rTMS involves no brain stimulation, but appears to the participant and provider to be active rTMS.

BEHAVIORAL

cognitive behavioral therapy for smoking cessation

All participants will receive five sessions of cognitive behavioral therapy (CBT) for smoking cessation.

DRUG

nicotine replacement therapy

All participants will receive nicotine replacement therapy in for the form of 21 mg, 14 mg, and/or 7 mg nicotine patches (based on smoking quantity) and a "rescue" method such as nicotine lozenge or nicotine gum.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Jonathan R Young, MD · Durham VA Medical Center, Durham, NC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-31
Primary Completion
2027-11-01
Completion
2027-11-01
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05723588 on ClinicalTrials.gov