Varenicline in Combination With Nicotine Replacement Therapy for Smoking Cessation
|Tobacco Dependence||Drug: Varenicline, Nicotine Patch Drug: Varenicline and Placebo Patch||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A 26-Week Phase II, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Varenicline in Combination With Nicotine Replacement Therapy for Smoking Cessation|
- continuous abstinence (CAR) from weeks 9 to 12 of treatment [ Time Frame: 3 months ]The primary endpoint is the 4-week continuous abstincence rate for week 9 - 12 of treatment, i.e. the proportion of patients who are able to maintain complete abstinence from cigarette smoking and other nicotine use, with end-expiratory exhaled carbon monoxide (CO) measurements 10 ppm or less, for the planned last 4 weeks of treatment.
- CAR from weeks 9 to 24 [ Time Frame: 6 months ]The secondary endpoint is the 4-week continuous abstincence rate for week 9 - 24 of treatment, i.e. the proportion of patients who are able to maintain complete abstinence from cigarette smoking and other nicotine use, with end-expiratory exhaled carbon monoxide (CO) measurements 10 ppm or less, for the planned last 4 weeks of treatment.
|Study Start Date:||April 2011|
|Study Completion Date:||June 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Placebo Comparator: Varenicline and Placebo Patch
Varenicline and Nicotine Patch (placebo)
Drug: Varenicline and Placebo Patch
placebo nicotine patches added to varenicline.
Active Comparator: Varenicline and Nicotine Patch
Varenicline and Nicotine Patch 15mg
Drug: Varenicline, Nicotine Patch
active nicotine patches added to varenicline.
This is a phase-II multicenter study involving 438 smokers, to be conducted at 7 sites in South Africa, over 6 months. In a randomized 1:1 allocation varenicline tartrate 1 mg twice daily, given in an incremental dosage for the first week before target quit date (TQD), will be compared to varenicline tartrate in the same dose combined with a 15mg nicotine patch. The nicotine patch (active and placebo) will be provided by McNeil. The patch will be given 2 weeks prior TQD. Treatment duration from TQD is 12 weeks with varenicline being tapered off during week 13.
A total of 12 clinic visits and 1 telephonic contact is planned for the 6-month study duration. The main efficacy outcome will be the 4-week continuous abstinence rate during the last four weeks of treatment, i.e. weeks 9 - 12. Efficacy assessments will be based on a Nicotine Use Inventory and measurements of end-expiratory exhaled carbon monoxide. Safety assessments will be based on adverse events evaluation, with special attention being given to the occurrence of nausea during the pretreatment period, as well as neuro-psychiatric symptoms such as depression or suicidal ideation. Participants will not be subjected to any invasive procedures.
This protocol is based on current evidence and two further abstracts presented at the European Respiratory Society Conference in Vienna, September 2009, that a combination of varenicline tartrate and nicotine replacement therapy indicate superior efficacy in cessation rate, but also an excellent good safety profile.
This study relates to the area of pharmacotherapy of smoking cessation, and will answer a frequently asked question. Importantly, several leading pulmonologists with experience in smoking cessation in South Africa have expressed their keen interest to participate in this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01444131
|Respiratory Research Unit|
|Cape Town, Western Cape, South Africa, 7505|
|Cape Town, Western Cape, South Africa, 7700|
|UCT Lung Institute|
|Cape Town, Western Cape, South Africa, 8000|
|Dr JA O'Brien|
|Cape Town, Western Cape, South Africa, 8001|
|Dr AHH Brüning|
|Gatesville / Cape Town, Western Cape, South Africa, 7764|
|Dr MS Abdool-Gaffar|
|Amanzimtoti, South Africa, 4126|
|Dr C Smith|
|Sandton, South Africa, 2010|
|Principal Investigator:||Elvis M Irusen, MBChB, FCP, PhD||University of Stellenbosch|