Neuromodulation for nicotine dependence in people with and without schizophrenia

Network-Targeted Neuromodulation for Nicotine Dependence in Schizophrenia

This study is testing two types of brain stimulation to see if they can help reduce nicotine cravings in people with and without schizophrenia.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Vanderbilt University Medical Center (Academic / other)
• Locations: 1 site (Nashville, Tennessee)
• Trial ID: NCT06389266 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare two types of transcranial magnetic stimulation (TMS) to assess their effects on nicotine craving in individuals with schizophrenia and those without psychosis. Participants will undergo either DMN-targeted continuous theta burst stimulation (cTBS) or L DLPFC-targeted intermittent theta burst stimulation (iTBS) to evaluate changes in brain connectivity and craving levels. The study will measure cognitive performance and craving before and after each week of TMS to determine the efficacy of each intervention. The goal is to understand how these brain circuits differ between the two populations and to identify effective treatment strategies for nicotine dependence.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-65 with a diagnosis of schizophrenia or schizoaffective disorder who are current nicotine users.

Not a fit: Patients without nicotine dependence or those with other psychiatric disorders not specified in the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to targeted treatments for nicotine dependence in individuals with schizophrenia, improving their overall health and quality of life.

How similar studies have performed: Previous studies have shown promising results with rTMS in treating nicotine dependence, but this specific approach targeting distinct brain circuits in schizophrenia is novel.

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

Where this trial is running

Nashville, Tennessee

• Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)

Study contacts

• Principal investigator: Heather B Ward, MD — Vanderbilt University Medical Center
• Study coordinator: Heather B Ward, MD

Conditions Schizophrenia; Nicotine Dependence