RecruitingNot ApplicableNCT04903028

RTMS Targets Neural Circuits for Smoking Cessation

RTMS Manipulates Imbalanced Drive-reward and Executive Control Circuitry for Smoking Cessation


Sponsor

Medical University of South Carolina

Enrollment

64 participants

Start Date

May 15, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 22 YearsMax Age: 70 Years

Inclusion Criteria10

  • 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 Criteria11

  • 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.

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Interventions

DEVICESham rTMS

Two electrodes on the scalp will be connected to transcutaneous electrical nerve stimulation.

DEVICEActive rTMS 10 Hz DLPFC

10 Hz repetitive transcranial magnetic stimulation (rTMS) will be delivered over left dorsolateral prefrontal cortex (DLPFC).


Locations(2)

Medical University of South Carolina

Charleston, South Carolina, United States

Medical University of South Carolina

Charleston, South Carolina, United States

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NCT04903028


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