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NCT06389266Completed

Network-Targeted Neuromodulation for Nicotine Dependence in Schizophrenia

Source: ClinicalTrials.gov · Last updated 17 Dec 2025

Brief summary (registry, in English)

The goal of this clinical trial is to compare two active types of transcranial magnetic stimulation in two nicotine-using populations: nicotine-using people with psychosis and nicotine-using people without a diagnosis of a psychotic disorder. The main questions it aims to answer are: 1. Can rTMS change functional connectivity in brain circuits associated with nicotine use? 2. Are those rTMS-induced changes in functional connectivity related to craving? Participants will complete tasks assessing their cognitive performance and craving before and after each week of TMS. Researchers will compare the effect of each TMS intervention on participants with and without psychosis to see if one type of TMS has an effect on nicotine craving.

Status (registry)
Completed
Study type
Interventional
Enrollment
90 (actual)
First submitted
24 Apr 2024
Start date
15 Jun 2023
Primary completion date
15 Sept 2025
Lead sponsor
Vanderbilt University Medical Center
NCT number
NCT06389266

What you commit to

  • Study type: Interventional
  • Participants enrolled: 90
  • From 15 Jun 2023 to the primary completion date, 15 Sept 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Any devices such as pacemaker, medication pump, nerve stimulator, transcutaneous electrical nerve stimulation (TENS) unit, ventriculo-peritoneal shunt unless cleared by the responsible covering MD
  • Any changes in medications or hospitalizations within the past 90 days.

Other illness

  • Substance use disorder (other than nicotine) within the past three months Positive urine drug screen for illicit substance use that can increase seizure risk (cocaine, benzodiazepines, amphetamine, methamphetamine)
  • Any history of a progressive or genetic neurologic disorder (e.g. Parkinson's disease, multiple sclerosis, tuberous sclerosis, Alzheimer's Disease) or acquired neurological disease (e.g. stroke, traumatic brain injury, tumor), including intracranial lesions
  • History of head trauma resulting in any loss of consciousness (\>15 minutes) or neurological sequelae
  • Current history of poorly controlled headaches including chronic medication for migraine prevention
  • History of fainting spells of unknown or undetermined etiology that might constitute seizures
  • History of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy with the exception of a single seizure of benign etiology (e.g. febrile seizures) in the judgment of a board-certified neurologist
  • Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
  • Medications will be reviewed by the responsible covering physician and a decision about inclusion will be made based on the participant's past medical history, drug dose, history of recent medication changes or duration of treatment, and use of central nervous system (CNS) active drugs. The published TMS guidelines review of medications to be considered with rTMS will be taken into consideration given their described effects on cortical excitability measures.

Age

  • All female participants of child-bearing age will be required to have a pregnancy test; any participant who is pregnant or planning to become pregnant will not be enrolled in the study

Other

  • DSM-5 intellectual disability
  • Any metal in the brain or skull (excluding dental fillings) or elsewhere in the body unless cleared by the responsible covering MD (e.g. MRI compatible joint replacement)
  • Participants who, in the investigator's opinion, might not be suitable for the study or would be unable to tolerate the study visit

Who the study is looking for

  • Age between 18-65 years
  • Diagnosis of either schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual for Mental Disorders (DSM-5) criteria and confirmed by Structured Clinical Interview for the DSM (SCID) (First et al. 2015)
  • Current nicotine use (confirmed by expired carbon monoxide or urine cotinine)
  • Must be able to read, speak and understand English
  • Must be judged by study staff to be capable of completing the study procedures
  • Participants will be in stable outpatient psychiatric treatment and psychiatrically stable with no recent (within the past 90 days) psychiatric hospitalizations or changes in their psychiatric medication regimens.
  • \- All of the above except for participants will not have a diagnosis of schizophrenia or schizoaffective disorder nor a first-degree relative with a psychotic disorder.

Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Vanderbilt University Medical Center
Coordinator of this site? Confirm its status
NashvilleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.