Network-Targeted Neuromodulation for Nicotine Dependence in Schizophrenia
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.
Conditions:
🦠 Schizophrenia 🦠 Nicotine Dependence
🗓️ Study Start (Actual) 15 June 2023
🗓️ Primary Completion (Estimated) 10 January 2029
✅ Study Completion (Estimated) 10 January 2029
👥 Enrollment (Estimated) 100
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Nashville, Tennessee, United States

📋 Eligibility Criteria

Description

  • Inclusion Criteria for Participants with Psychosis:
  • * 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.
  • Inclusion Criteria for People without Psychosis:
  • - 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.
  • Exclusion Criteria for All Participants:
  • * DSM-5 intellectual disability
  • * 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.)
  • * 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)
  • * 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
  • * 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
  • * 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.
  • * Any changes in medications or hospitalizations within the past 90 days.
  • * Participants who, in the investigator's opinion, might not be suitable for the study or would be unable to tolerate the study visit
Ages Eligible for Study: 18 Years to 65 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 24 April 2024
  • First Submitted that Met QC Criteria 24 April 2024
  • First Posted 29 April 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 24 April 2024
  • Last Update Posted 29 April 2024
  • Last Verified April 2024