NCT04903028 RTMS Targets Neural Circuits for Smoking Cessation
| NCT ID | NCT04903028 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of South Carolina |
| Condition | Tobacco Use |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2021-05-15 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 64 participants in total. It began in 2021-05-15 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Cigarette smoking is a significant public health concern. Transcranial magnetic stimulation (TMS) is a non-invasive form of brain stimulation that has already displayed remarkable potential for producing novel, non-pharmacological interventions for depression and cigarette smokers. In this study, investigators will use brain MRI to guide TMS therapy for smoking cessation.
Eligibility Criteria
Inclusion Criteria * Be between the ages of 22 and 70 years old. * Smoke 10 or more cigarettes per day and have a carbon monoxide (CO) level \> 10 ppm indicative of recent smoking. * Have not received substance abuse treatment within the previous 30 days. * Meet the criteria for tobacco use disorder as determined by DSM-5. * Be in stable mental and physical health. * If female, test non-pregnant and use adequate birth control. * Show no evidence of focal or diffuse brain lesions on MRI. * Be willing to provide informed consent. * Be able to comply with protocol requirements and likely to complete all study procedures. * Be motivated to quit smoking (based on responses of "very likely," or "somewhat likely" in the motivation questionnaire). Exclusion Criteria * Current moderate to severe substance use of any psychoactive substances other than nicotine or caffeine, as defined by DSM-V criteria. * Contraindications to MRI (e.g., presence of metal in the skull, orbital or intracranial cavity, or having claustrophobia). * Contraindication to rTMS. * History of autoimmune, endocrine, viral, or vascular disorders affecting the brain. * History or MRI evidence of neurological disorder that would lead to local or diffuse brain lesions or significant physical impairment. * Unstable cardiac disease, uncontrolled hypertension, severe renal or liver insufficiency, or sleep apnea. * Lifetime history of major Axis I disorders such as: bipolar affective disorder (BPAD), schizophrenia, post-traumatic stress disorder (PTSD), dementia, suicidal ideation or major depression. * Self-report of \>21 standard alcohol drinks per week in any week in the 30 days prior to screening. * Use of other forms of nicotine delivery, such as nicotine patches, electronic cigarettes, gum, nasal spray, inhalers, and nicotine lozenges. * Use of other tobacco products, including cigars, cigarillos, chew, snuff, and pouches/snus. * Previous treatment with TMS.
Contact & Investigator
Xingbao Li, MD, MSCR, MS
PRINCIPAL INVESTIGATOR
Medical University of South Carolina
Frequently Asked Questions
Who can join the NCT04903028 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, up to 70 Years, studying Tobacco Use. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04903028 currently recruiting?
Yes, NCT04903028 is actively recruiting participants. Contact the research team at lixi@musc.edu for enrollment information.
Where is the NCT04903028 trial being conducted?
This trial is being conducted at Charleston, United States, Charleston, United States.
Who is sponsoring the NCT04903028 clinical trial?
NCT04903028 is sponsored by Medical University of South Carolina. The principal investigator is Xingbao Li, MD, MSCR, MS at Medical University of South Carolina. The trial plans to enroll 64 participants.