NICOTINE DEPENDENCE. MedDRA version: 14.0 Level: LLT Classification code 10032707 Term: Other specified drug dependence, continuous use System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 14.0 Level: LLT Classification code 10012336 Term: Dependence addictive System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: CHAMPIX
Product Name: VARENICLINE
Product Code: SUB25195
Pharmaceutical Form: Tablet
INN or Proposed INN: VARENICLINE
CAS Number: 249296-44-4
Concentration unit: mg milligram(s)
Concentrat
Sponsors
HOSPITAL UNIVERSITARI DE BELLVITGE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: i) Aged 18 to 65 years old ii) Smoking 20 or more cigarettes per day, who wants to stop smoking (seeking treatment), and who has no period of smoking abstinence longer than 3 months in the past year. iii)Be able to give informed consent to participate and to complete the study questionnaires. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 322 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: i) Previous use of nicotine transdermal patches or varenicline (VRN) in the last 6 months ii) Cigar, pipe and oral tobacco users who do not smoke 20 or more cigarettes per day iii) Those who meet the criteria contra-indicating nicotine patches or VRN use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of combined therapy (VRN+nicotine patches) versus monotherapy (VRN+placebo patches) in smoking cessation assessed as continuous abstinence rate (CAR) from week 2 to week 12;Secondary Objective: i) To determine safety of combined therapy (VRN+nicotine patches) versus monotherapy (VRN+placebo patches) ii) To determine the withdrawal and craving relief according to combined therapy (VRN+nicotine patches) or monotherapy (VRN+placebo patches). iii) To determine the efficacy of combined therapy (VRN+nicotine patches) versus monotherapy (VRN+placebo patches) assessed as continuous abstinence rate (CAR) at long time (52 weeks). iv) To determine the efficacy of combined therapy (VRN+nicotine patches) versus monotherapy (VRN+placebo patches) according to 3OHcotinine/Cotinine ratio.;Primary end point(s): To idetermine continuous abstinence rate (CAR) from week 2 to week 12 measured objectively by the CO exhaled;Timepoint(s) of evaluation of this end point: Biweekly at visits or weeks 2 (w2), 3 (w4), 4 (w6), 5 (w8), 6 (w10) and 7 (w12). | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: At visits or weeks 1 (w1), 7 (w12), 8 (w24), and 11 (w52).;Secondary end point(s): To determine efficacy, safety and cravings appearances of combined therapy (VRN+nicotine patches) versus monotherapy (VRN+placebo patches) mesured objectively by the BDI, SSI, SIS and HARS scales as well as self-reports, physical examination | — |
Countries
Spain
Contacts
Public ContactJOSÉ MARIA RAMON TORRELL
HOSPITAL UNIVERSITARI DE BELLVITGE
Outcome results
None listed