Clinical Trial to Evaluate the Efficacy of Smoking Cessation
COMBIVAR
Randomized Double-blind Trial of Two Parallel Groups Design to Evaluate the Efficacy of Smoking Cessation With Combined (Varenicline Plus Nicotine Patches) Versus Monotherapy (Varenicline Plus Placebo Patches)
1 other identifier
interventional
322
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 14, 2012
CompletedFirst Posted
Study publicly available on registry
February 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedOctober 18, 2013
October 1, 2013
1.4 years
February 14, 2012
October 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
The primary endpoint will be the continuous abstinence rate (CAR) from week 2 (w2) to week 12 (w12) measured objectively during the treatment phase by the CO exhaled.
Participants will be followed for the duration of treatment, 12 weeks.
Secondary Outcomes (1)
i) Determine safety of combined therapy (VRN+nicotine patches) versus monotherapy (VRN+placebo patches)
Every two weeks from week 2 to 12
Study Arms (2)
Varenicline & nicotine patches
EXPERIMENTALCombined therapy by using Varenicline plus nicotine patches.The intervention-phase will comprise two fasses: * Pre-NRT: Patients take 1 week VRN impregnation (0.5mg/day during the first 3 days + 0.5mg twice daily for the next for days) * Treatment: starting at day 8 and during the next 11 weeks patients continue taking VRN 1mg twice daily plus placebo transdermal patches of 30cm2/24 hours per 8 weeks and then 20cm2/24 hours per 3 weeks.
Varenicline & placebo patches
PLACEBO COMPARATORMonotherapy by using Varenicline plus placebo patches.The intervention-phase will comprise two fasses: * Pre-NRT: Patients take 1 week VRN impregnation (0.5mg/day during the first 3 days + 0.5mg twice daily for the next for days) * Treatment: starting at day 8 and during the next 11 weeks patients continue taking VRN 1mg twice daily plus nicotine transdermal patches of 30cm2/24 hours per 8 weeks and then 20cm2/24 hours per 3 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Related Publications (2)
Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
PMID: 37142273DERIVEDRamon JM, Morchon S, Baena A, Masuet-Aumatell C. Combining varenicline and nicotine patches: a randomized controlled trial study in smoking cessation. BMC Med. 2014 Oct 8;12:172. doi: 10.1186/s12916-014-0172-8.
PMID: 25296623DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
JOSEP M RAMON TORRELL, PhD
Hospital Universitari de Bellvitge
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Josep Maria Ramon Torrell
Study Record Dates
First Submitted
February 14, 2012
First Posted
February 24, 2012
Study Start
January 1, 2012
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
October 18, 2013
Record last verified: 2013-10