COMBIVAR. Trial of two parallel groups to evaluate the efficacy of smoking cessation with combined versus monotherapy

• Conditions: ICOTINE DEPENDENCE.; MedDRA version: 14.0Level: LLTClassification code 10032707Term: Other specified drug dependence, continuous useSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 14.0Level: LLTClassification code 10012336Term: Dependence addictiveSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-004692-36-ES
• Lead Sponsor: HOSPITAL UNIVERSITARI DE BELLVITGE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified