What this study is
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.
What's being tested
- active repetitive transcranial magnetic stimulation
Intervention · 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
Intervention · DEVICE
Sham rTMS involves no brain stimulation, but appears to the participant and provider to be active rTMS.
- cognitive behavioral therapy for smoking cessation
Intervention · BEHAVIORAL
All participants will receive five sessions of cognitive behavioral therapy (CBT) for smoking cessation.
- nicotine replacement therapy
Intervention · 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
- Sponsor
- VA Office of Research and Development
- Conditions
- Tobacco Use Disorder
- Enrolling
- 50 people
- Starts
- 2023-10-31
- Est. completion
- 2027-11-01
- Design
- Triple-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 75 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Is a US Veteran
- Meets DSM-5 criteria for tobacco use disorder
- Is between the ages of 18 and 75
- Smokes an average of 10 cigarettes per day for the past 6 months, with carbon monoxide (CO) level > 6 ppm
- Is willing to attempt smoking cessation
- Meets DSM-5 criteria for current PTSD diagnosis
- Speaks, reads and writes English
- Is willing to sign a Duke consent for those portions of the study that occur at Duke
- Has been stable on psychotropic medications for at least three months
You can't join if
- Has had a substance use disorder other than tobacco in the preceding 3 months
- Has a history of myocardial infarction in the past 6 months or has another contraindication to NRT
- Has a contraindication to TMS or MRI; Personal or family history of a seizures or epilepsy; History of neurological condition that increases the risk of seizures including stroke or transient ischemic attack, cerebral aneurysm, or severe traumatic brain injury from a penetrating head injury, loss of consciousness > 20 minutes at time of traumatic injury, requiring an anticonvulsant medication for seizures, and/or found to have encephalomalacia on baseline MRI; Structural brain lesion, or prior brain surgery; Ferromagnetic metal in head (including shrapnel); Implanted devices that may be affected by MRI or TMS (pacemaker, medication pump, cochlear implant, implanted deep brain stimulator); Is pregnant (to be determined at Duke)
- Is unable to complete study procedures
- Is currently prescribed bupropion and/or varenicline
- Uses other forms of nicotine such as cigars, pipes, chewing tobacco, or vaping
- Is unable to provide informed consent due to a major neurocognitive disorder or other reason
- Meets criteria for a primary psychotic disorder or current manic episode
- Is currently imprisoned or psychiatrically hospitalized
- Has previously received rTMS
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openDurham VA Medical Center, Durham, NC
Durham, North Carolina, United States
- Susanna B Oberg, AAS AAS · Contact615-873-6955susanna.oberg@va.gov
- Jonathan R Young, MD · Principal investigator
Recruiting
Study team
Sponsor
VA Office of Research and Development
Study ID NURA-001-22S
Principal investigator
Jonathan R Young, MD
Durham VA Medical Center, Durham, NC
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.