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

Part of paid clinical trials in Durham, North Carolina.

Sponsor
VA Office of Research and Development
Study ID
NCT05723588
Phase
PHASE2
Status
Recruiting
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Conditions

  • Tobacco Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • active repetitive transcranial magnetic stimulation — DEVICE
    Active rTMS is a non-invasive brain stimulation intervention that is FDA cleared as a treatment for smoking cessation in adults.
  • sham repetitive transcranial magnetic stimulation — DEVICE
    Sham rTMS involves no brain stimulation, but appears to the participant and provider to be active rTMS.
  • cognitive behavioral therapy for smoking cessation — BEHAVIORAL
    All participants will receive five sessions of cognitive behavioral therapy (CBT) for smoking cessation.
  • nicotine replacement therapy — DRUG
    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.

Study Details

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.

Key Dates

Start date
Oct 31, 2023
Status verified
Feb 2026
Primary completion
Nov 1, 2027
Completion
Nov 1, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: active rTMS
    Participants assigned to this group will receive active repetitive transcranial magnetic stimulation (rTMS) as part of their smoking cessation treatment.
  • Sham Comparator: sham rTMS
    Participants assigned to this group will receive sham repetitive transcranial magnetic stimulation (rTMS) as part of their smoking cessation treatment.

Primary Outcome Measure

Feasibility as measured by number of participants recruited [ Time Frame: At consent ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Durham VA Medical Center, Durham, NCDurhamNorth Carolina27705-3875
Susanna B Oberg, AAS AAS
[email protected]
615-873-6955
Jonathan R Young, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Durham VA Medical Center, Durham, NC· Durham, NC

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