Nicotine use disorder. Nicotine dependence
Conditions
Interventions
Intervention 1: Intervention Group - Varenicline: During the first three days of the treatment program, 0.5 mg of varenicline is administered daily. On the fourth day, the dosage is increased to 0.5 m
Sponsors
Iran University of Medical Sciences
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Age between 18 and 65 years. Male gender. Daily consumption of more than ten cigarettes for at least two years (in the nicotine use disorder group, confirmed by an FTND score of 4 or higher). No lifetime history of nicotine use disorder (in the healthy control group). Absence of psychotic spectrum disorders or bipolar disorders. No use of alcohol, marijuana, or other substances such as Methamphetamine, Opioids, or Benzodiazepines. Not participating in other treatment programs at the time of enrollment in the study.
Exclusion criteria
Exclusion criteria: Severe, uncontrolled medical conditions Acute, uncontrolled psychiatric disorders Active dependence on other substances Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Craving: A term that encompasses a range of phenomena, including the anticipation of the reinforcing effects of substances, the intention to use substances, and a strong inclination toward substances. Timepoint: Pre-test, Post-test, 1-Month Follow-up, and 3-Month Follow-up. Method of measurement: The score obtained by the individual from the DCQ-12 questionnaire.;Anxiety: In the cognitive dimension, it involves negative mood and concern about potential danger. In the physiological dimension, it is characterized by a state of tension and excessive, chronic arousal in response to an issue that does not have an external existence. Timepoint: Pre-test, Post-test, 1-Month Follow-up, and 3-Month Follow-up. Method of measurement: The score obtained by the participant from the SCL-25 Anxiety and Depression Scale.;Brain-Derived Neurotrophic Factor (BDNF): A protein encoded by the BDNF gene, belonging to the neurotrophin family, which promotes the development of neural networks. Brain-derived neurotrophic factor is one of the most important members of this family and, by binding to specific tyrosine kinase receptors, triggers intracellular cascades that ultimately lead to the production and differentiation of new neurons. Timepoint: pre test_post test. Method of measurement: Serum levels of BDNF will be measured using the ELISA technique.;Executive Function: Executive function is a broad construct encompassing a wide range of cognitive processes and behavioral abilities, including reasoning, problem-solving, planning, organizing, working memory, sequencing, sustained attention, interference control, utilizing feedback, multitasking, updating, and inhibition. Timepoint: Pre-test, Post-test, 1-Month Follow-up, and 3-Month Follow-up. Method of measurement: The score obtained by the participant from the Stroop Test.;Attention: Refers to the ability to select and focus on related stimuli. Timepoint: Pre-test, Post-test, 1-Month Follow-up, and 3-Month Follow-up. Method of measureme | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Mohsen Roshanpajouh
Iran University of Medical Sciences
Outcome results
None listed