N/A
N=42
Repetitive Transcranial Magnetic Stimulation (rTMS) for Nicotine Addiction
Nicotine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT02401672 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Nicotine Consumption: Number of Cigarettes Per Day — 11.60; 13.73 the number of cigarette — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcranial magnetic stimulation (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Nicotine Consumption: Number of Cigarettes Per Day |
11.60; 13.73 | 0.05 |
| PRIMARY Percentage of Change of Cigarettes Per Day |
62.93; 38.43 | 0.05 |
| SECONDARY Average Nicotine Craving as Assessed by the Questionnaire of Smoking Urges-Brief |
25.01; 29.93 | 0.05 |
| SECONDARY The Number of Participants Quitting on the Target Quit Date |
5; 0 | 0.05 |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02401672). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.