nicotine dependence
Conditions
Interventions
Intervention group An intervention (trial drug administration) period: 12 weeks 1 pack (2.5g), three times a day(7.5g/day),take before breakfast,lunch and dinner.
Placebo group An intervention (tri
Sponsors
National Hospital Organization Kyoto
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Current smokers with nicotine dependency (FTND 5 point or more), who wish to quit smoking. 2.Patients with depressed tendency: SDS tests are 59 points or less and 39 points or more. 3.Patients not receiving medication at psychiatric/psychosomatic medical department. 4.Outpatients
Exclusion criteria
Exclusion criteria: Patients were excluded from this study based on a pre-trial examination and when their attending physician determined that they met at least one of the following conditions: (1) administration of yokukansan would be inadvisable based on their general condition (2) complications by diseases such as severe liver disease (Child-Pugh classification of C), kidney disease (creatinine clearance of under 15 ml/min), and uncontrolled endocrine disease, (3) consistent use of drugs containing large amounts of licorice and glycyrrhizic acid, (4) history of yokukansan allergy, (5) currently experiencing symptoms of allergy due to some drug, (6) currently pregnant, nursing, or intend to become pregnant during the study period, (7) the attending physician determines that participation in this study would be inappropriate for any other reason (e.g. inability to understand the contents of the study due to dementia).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of achievement of smoking cessation after 12 weeks from the start of test drug administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) the degree of change in the SDS/POMS scores from the pre-drug administration screening to the +12W time point (assessment of post-SC depression), (2) adverse events during the trial drug administration period. | — |
Countries
Japan
Contacts
Public ContactKoji Hasegawa
National Hospital Organization Kyoto Division of Translational Research
Outcome results
None listed