Status:
RECRUITING
RTMS Targets Neural Circuits for Smoking Cessation
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Tobacco Use
Cigarette Smoking
Eligibility:
All Genders
22-70 years
Phase:
NA
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 produc...
Detailed Description
Smoking cessation is difficult, despite the demonstrated efficacy of several pharmacotherapeutic agents and cognitive behavioral therapies. This may be due to imbalanced neuronal circuits, including e...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 4 2027
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04903028
Start Date
May 15 2021
End Date
April 4 2027
Last Update
April 10 2025
Active Locations (2)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
2
Medical University of South Carolina
Charleston, South Carolina, United States, 29425