Nicotine dependence (cigarette smoking). Nicotine dependence
Conditions
Interventions
Intervention 1: Intervention group: Participants in this group receive an intranasal spray containing oxytocin. The spray includes 40 International Units (IU) of oxytocin per daily dose, administered
Sponsors
Kashan University of Medical Sciences
Eligibility
Sex/Gender
Male
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Willingness and informed consent to participate in the study Diagnosis of schizophrenia Being a current smoker Minimum education level of primary school Having stable schizophrenia symptoms Stable psychiatric medication regimen in terms of type and dose Being male
Exclusion criteria
Exclusion criteria: Current use of substances such as cannabis or opioids Having chronic physical illnesses such as AIDS, hepatitis, liver disease, kidney disease, or heart disease at the time of enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Score of nicotine craving using the Nicotine Dependence Syndrome Scale (NDSS) in smokers with schizophrenia; to assess the intensity of craving. Timepoint: Measurement at baseline (prior to intervention with oxytocin or placebo) and at the end of week six (after completing the 6-week nasal spray intervention). Method of measurement: Nicotine Dependence Syndrome Scale questionnaire.;Clinical symptom score using the PANSS (Positive and Negative Syndrome Scale) in smokers with schizophrenia; to evaluate severity of positive, negative, and total symptoms. Timepoint: Measurement at baseline (prior to intervention with oxytocin or placebo) and at the end of week six (after completing the 6-week nasal spray intervention). Method of measurement: Positive and Negative Syndrome Scale questionnaire.;Cognitive performance score using the Montreal Cognitive Assessment (MoCA) in smokers with schizophrenia; to assess cognitive impairments including memory and attention. Timepoint: Measurement at baseline (prior to intervention with oxytocin or placebo) and at the end of week six (after completing the 6-week nasal spray intervention). Method of measurement: Montreal Cognitive Assessment questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Sleep quality score using the Pittsburgh Sleep Quality Index (PSQI) in smokers with schizophrenia; to assess sleep quality. Timepoint: Measurement at baseline (prior to intervention with oxytocin or placebo) and at the end of week six (after completing the 6-week nasal spray intervention). Method of measurement: Pittsburgh Sleep Quality Index questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public Contactfatemeh mehrzad
Kashan University of Medical Sciences
Outcome results
None listed