BridgeMD
New treatment option for Tobacco Use Disorder
Official title Neuroimaging Correlates and Feasibility of Transcranial Magnetic Stimulation (TMS) to Improve Smoking Cessation Outcomes in Veterans With Comorbid PTSD
ClinicalTrials.gov ID: NCT05723588
What this study is testing
What is nicotine replacement therapy?
nicotine replacement therapy is an investigational medicine, being studied as a potential treatment for tobacco use disorder.
Also referred to as NRT, nicotine patch, nicotine gum, nicotine lozenges.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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
You likely 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...
- Structural brain lesion, or prior brain surgery
See the full eligibility criteria
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Durham, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Durham, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.