Repetitive Transcranial Magnetic Stimulation (rTMS) for Nicotine Addiction
rTMS
Developing rTMS as a Potential Treatment for Nicotine Addiction
1 other identifier
interventional
42
1 country
1
Brief Summary
Cigarette smoking remains a significant public health concern. A magnetic field applied to the outside of the skull can produce electrical activity in the brain without significant pain or the need for anesthesia. Sessions of magnetic stimulation or superficial stimulation that does not reach the brain will be used to determine if magnetic stimulation can reduce cue-induced craving and cigarettes consumption in adult nicotine-dependent cigarette smokers. This project may lead to a new therapy for smoking cessation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 14, 2014
CompletedFirst Submitted
Initial submission to the registry
March 16, 2015
CompletedFirst Posted
Study publicly available on registry
March 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2018
CompletedResults Posted
Study results publicly available
September 21, 2020
CompletedSeptember 21, 2020
August 1, 2020
4.6 years
March 16, 2015
March 30, 2020
August 31, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Nicotine Consumption: Number of Cigarettes Per Day
Nicotine consumption: We use cigarette diary for participant to record number of cigarettes smoked per day.
2 weeks of treatment
Percentage of Change of Cigarettes Per Day
percentage of change of cigarettes per day =100\* ( cigarettes smoked per day at baseline - cigarettes smoked per day at the end of treatment) / cigarettes smoked per day at baseline
2 weeks
Secondary Outcomes (2)
Average Nicotine Craving as Assessed by the Questionnaire of Smoking Urges-Brief
2 weeks of treatment
The Number of Participants Quitting on the Target Quit Date
2 weeks of treatment
Study Arms (2)
Active TMS
ACTIVE COMPARATORRepetitive TMS pulse stimulation
Sham TMS
SHAM COMPARATORThe sham TMS system will be connected to an electrical generator on a 9 V battery and electrodes will be placed over the prefrontal cortex. The regulator is triggered by the TMS machine to allow brief, microsecond, pulses of the electrical current through to the skin on the subjects' forehead. Electrical stimulation will be triggered by the TMS machine to correspond to the sham TMS pulses.
Interventions
Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual. A localized pulsed magnetic field transmitted through a TMS coil is able to focally stimulate the cortex by depolarizing superficial neurons inducing electrical currents in the brain. If TMS pulses are delivered repetitively and rhythmically, the process is called repetitive TMS (rTMS).
Eligibility Criteria
You may qualify if:
- Be between the ages of 18 and 60 years old.
- Smoke 10 or more cigarettes per day and have a carbon monoxide (CO) level \> 10 ppm indicative of recent smoking.
- Not received substance abuse treatment within the previous 30 days.
- Meet criteria for nicotine dependence as determined by the FTND.
- Be in stable mental and physical health.
- If female, test non-pregnant and use adequate birth control.
- No evidence of focal or diffuse brain lesion on MRI.
- Be willing to provide informed consent.
- Be able to comply with protocol requirements and likely to complete all study procedures.
You may not qualify if:
- Current dependence, defined by DSM-V criteria, on any psychoactive substances other than nicotine or caffeine.
- Contraindication to MRI (e.g., presence of metal in the skull, orbits or intracranial cavity, claustrophobia).
- Contraindication to rTMS (history of neurological disorder or seizure, increased intracranial pressure, brain surgery, or head trauma with loss of consciousness for \> 15 minutes, implanted electronic device, metal in the head, or pregnancy).
- History of autoimmune, endocrine, viral, or vascular disorder 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.
- Life time history of major Axis I disorders such as: Bipolar Affective disorder (BPAD), Schizophrenia, Post-traumatic Stress disorder (PTSD) or Dementia or Major Depression.
- Self report of \>21 standard alcohol drinks per week in any week in the 30 days prior to screening.
- Other forms of nicotine delivery, such as nicotine patch, electronic cigarettes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Related Publications (3)
Li X, Hartwell KJ, Owens M, Lematty T, Borckardt JJ, Hanlon CA, Brady KT, George MS. Repetitive transcranial magnetic stimulation of the dorsolateral prefrontal cortex reduces nicotine cue craving. Biol Psychiatry. 2013 Apr 15;73(8):714-20. doi: 10.1016/j.biopsych.2013.01.003. Epub 2013 Feb 26.
PMID: 23485014BACKGROUNDLi X, Caulfield KA, Hartwell KJ, Henderson S, Brady KT, George MS. Reduced executive and reward connectivity is associated with smoking cessation response to repetitive transcranial magnetic stimulation: A double-blind, randomized, sham-controlled trial. Brain Imaging Behav. 2024 Feb;18(1):207-219. doi: 10.1007/s11682-023-00820-3. Epub 2023 Nov 23.
PMID: 37996557DERIVEDLi X, Hartwell KJ, Henderson S, Badran BW, Brady KT, George MS. Two weeks of image-guided left dorsolateral prefrontal cortex repetitive transcranial magnetic stimulation improves smoking cessation: A double-blind, sham-controlled, randomized clinical trial. Brain Stimul. 2020 Sep-Oct;13(5):1271-1279. doi: 10.1016/j.brs.2020.06.007. Epub 2020 Jun 10.
PMID: 32534252DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Xingbao Li, MD
- Organization
- Medical University of South Carolina
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 16, 2015
First Posted
March 30, 2015
Study Start
May 14, 2014
Primary Completion
December 30, 2018
Study Completion
December 30, 2018
Last Updated
September 21, 2020
Results First Posted
September 21, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share