Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
96 participants
OBSERVATIONAL
2025-08-20
2026-12-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Voxel-Based Morphometry (VBM), an advanced neuroimaging analysis technique, allows for the detection of subtle structural changes in the brain using MRI data. This study aims to utilize VBM to explore GM alterations in three participant groups:
Schizophrenic patients without nicotine dependence
Schizophrenic patients with nicotine dependence
Individuals with nicotine dependence but without schizophrenia
Each group will include 32 participants, making a total sample of 96, calculated using G\*Power software assuming a medium effect size, alpha 0.05, and power 0.8. Inclusion criteria include confirmed diagnoses based on DSM-5 and the Fagerström Test for Nicotine Dependence, age 18-60, and MRI compatibility. Exclusion criteria involve other psychiatric or neurological disorders, substance use other than nicotine, and MRI contraindications.
Participants will undergo:
Structural MRI scans
Behavioral assessment using the Barratt Impulsiveness Scale
Clinical interviews using the Structured Clinical Interview for DSM-5
The primary outcome is to identify distinct patterns of GM reduction or alteration across groups, especially in regions involved in decision-making (e.g., prefrontal cortex, anterior cingulate cortex) and reward processing (e.g., ventral striatum). Secondary outcomes include correlating these structural findings with impulsivity and decision-making patterns.
Statistical analysis will be performed using SPSS v26. ANOVA will be used for quantitative comparisons across the three groups, while Chi-square or Fisher's exact tests will compare categorical variables. Pearson's correlation will be used to explore associations between brain changes and behavioral traits. A p-value \<0.05 will be considered significant.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
fMRI Study of Nicotinic Effect on Neurophysiology of Schizophrenia
NCT01046526
Brain Circuits in Schizophrenia and Smoking
NCT01369966
The Difference of Grey Matter Volume Among the Patients of Schizophrenia
NCT05262790
Neural Inhibition as a Mechanism of Nicotine Dependence Among Persons With Schizophrenia
NCT00407277
Magnetic Resonance Imaging (MRI) of Neuropsychiatric Patients and Healthy Volunteers
NCT00001284
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Voxel-Based Morphometry (VBM) is a widely used neuroimaging technique that enables researchers to detect and quantify brain structural differences, particularly in GM, by analyzing MRI scans. VBM allows for the identification of subtle brain abnormalities that may contribute to the development of schizophrenia and nicotine dependence. These structural changes may provide insight into associated behavioral traits such as impaired decision-making and increased impulsivity, both of which are commonly observed in individuals with either or both conditions
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Schizophrenic patients without nicotine dependence
MRI
structural MRI imaging and behavioral testing (e.g. Barratt Impulsiveness scale) both performed by skilled physicians.
Schizophrenic patients with nicotine dependence
MRI
structural MRI imaging and behavioral testing (e.g. Barratt Impulsiveness scale) both performed by skilled physicians.
Individuals with nicotine dependence but without schizophrenia
MRI
structural MRI imaging and behavioral testing (e.g. Barratt Impulsiveness scale) both performed by skilled physicians.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MRI
structural MRI imaging and behavioral testing (e.g. Barratt Impulsiveness scale) both performed by skilled physicians.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Nicotine dependence as defined by the Fagerström Test for Nicotine Dependence (for groups 2 and 3).
* Age range: 18-60 years.
* Schizophrenic patients must be stable on medications for at least 2 months.
* Written informed consent (from the patient or his carer).
Exclusion Criteria
* Current substance use disorders other than nicotine.
* Severe head trauma or other conditions likely to affect brain structure.
* IQ below 70.
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Assiut University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hesham Mohammed Abdel-Moty
Prinicipal investigator
References
Explore related publications, articles, or registry entries linked to this study.
Du X, Choa FS, Chiappelli J, Bruce H, Kvarta M, Summerfelt A, Ma Y, Regenold WT, Walton K, Wittenberg GF, Hare S, Gao S, van der Vaart A, Zhao Z, Chen S, Kochunov P, Hong LE. Combining neuroimaging and brain stimulation to test alternative causal pathways for nicotine addiction in schizophrenia. Brain Stimul. 2024 Mar-Apr;17(2):324-332. doi: 10.1016/j.brs.2024.02.020. Epub 2024 Mar 5.
Wilke M, Kaufmann C, Grabner A, Putz B, Wetter TC, Auer DP. Gray matter-changes and correlates of disease severity in schizophrenia: a statistical parametric mapping study. Neuroimage. 2001 May;13(5):814-24. doi: 10.1006/nimg.2001.0751.
Liu H, Guan L, Nie Y, Li Q, Xue J, Yang Y, Rong S, Liang J, Guan Y, Zhai F, Ren Y, An Z, Dong Z, Han Z. Brain Magnetic Resonance Imaging Features of Nicotine-Dependent Individuals and Its Correlation with Polymorphisms of Dopamine D Receptor Gene. Contrast Media Mol Imaging. 2022 Aug 24;2022:2296776. doi: 10.1155/2022/2296776. eCollection 2022.
Brown GG, Lee JS, Strigo IA, Caligiuri MP, Meloy MJ, Lohr J. Voxel-based morphometry of patients with schizophrenia or bipolar I disorder: a matched control study. Psychiatry Res. 2011 Nov 30;194(2):149-56. doi: 10.1016/j.pscychresns.2011.05.005. Epub 2011 Sep 15.
Segall JM, Turner JA, van Erp TG, White T, Bockholt HJ, Gollub RL, Ho BC, Magnotta V, Jung RE, McCarley RW, Schulz SC, Lauriello J, Clark VP, Voyvodic JT, Diaz MT, Calhoun VD. Voxel-based morphometric multisite collaborative study on schizophrenia. Schizophr Bull. 2009 Jan;35(1):82-95. doi: 10.1093/schbul/sbn150. Epub 2008 Nov 7.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCTMRISCHIZ2025
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.