Clinical Trial to Evaluate the Efficacy of Smoking Cessation

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the efficacy of smoking cessation by using varenicline as monotherapy (VRN + placebo patches) or combined therapy (VRN + nicotine patches).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Josep Maria Ramon Torrell, PhD
• Treatments: Nicotine; Varenicline

Criteria

Inclusion Criteria:

• Aged 18 to 65 years old

• Smoking 20 or more cigarettes per day

• Wants to stop smoking(seeking treatment)

• No period of smoking abstinence longer than 3 months in the past year

• Be able to give informed consent to participate

• Complete the study questionnaires

• Female smokers will be eligible providing they are not breastfeeding, pregnant (negative pregnancy test) or at risk of becoming pregnant

Exclusion Criteria:

• Previous use of nicotine transdermal patches or varenicline (VRN) in the last 6 months

• Cigar, pipe and oral tobacco users who do not smoke 20 or more cigarettes per day

• Those who meet the criteria contra-indicating nicotine patches or VRN use, as described in the Summaries Product Characteristics

• Those with previous severe adverse reactions to nicotine patch or to VRN

• Those currently taking either medication for smoking cessation that they are unwilling to stop or taking medication with a known influence on smoking cessation that they should not stop (e.g. nortriptyline for depression)

• Those who are non-Spanish neither Catalan speakers

• Those deemed unsuitable for the study by their smoking cessation physicians; -- Unstable diseases within the previous 6 months

• Diagnoses of or treatment for major depression last 6 months or psychotic disorder; or drug or alcohol dependence within the previous 12 months

• Skin disorders that cause a difficulty of nicotine absorption by patches as Psoriases as well as general dermatitis

• Clinically significant renal or hepatic impairment or dysfunction

• Pregnant or breast-feeding women

• women who do not use neither want to use any effective anticonceptive method.