Network-Targeted Neuromodulation for Nicotine Dependence in Schizophrenia

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Apr 24, 2024

Keywords

ClinConnect Summary

The clinical trial titled "Network-Targeted Neuromodulation for Nicotine Dependence in Schizophrenia" is studying how a type of brain stimulation called transcranial magnetic stimulation (TMS) can help reduce cravings for nicotine. The researchers want to see if TMS can change the way certain brain circuits work in people who use nicotine—specifically comparing those with schizophrenia or psychosis to those without. They will assess participants' thinking abilities and cravings before and after each week of TMS treatment.

To participate, you need to be between 18 and 65 years old and currently use nicotine. If you have schizophrenia or a similar condition, you can join, but if you don’t have a psychotic disorder, you must not have a close family member with one. Participants will be closely monitored and must be stable in their mental health treatment. Throughout the study, participants can expect to complete tasks related to their cognitive performance and cravings while receiving TMS treatment aimed at helping them overcome their nicotine dependence.

Gender

ALL

Eligibility criteria

• 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