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Meclizine for Smoking Cessation
NCT01443858Phase 2
Key facts
- Status
- Completed
- Start
- Aug 2011
- Primary completion
- Dec 2012
- Countries
- 1
- Sponsor
- Duke University
- Modality
- Orthosteric Ligands
- Drugs
- meclizine
- Conditions
- nicotine dependence
01
Overview
Phase 2, randomised, double-blind trial of meclizine in nicotine dependence (3 arms), sponsored by Duke University. Primary endpoints: Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 1 and Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 3. Started Aug 2011; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Placebo + Nicotine Patch
Placebo Meclizine (Pre-quit) + Nicotine Patch
25mg Meclizine + Nicotine Patch
25mg Meclizine (Pre-quit) + Nicotine Patch
50mg Meclizine + Nicotine Patch
50mg Meclizine (Pre-quit) + Nicotine Patch
03
Who it enrols
Adult smokers (18-65 years) smoking at least 10 cigarettes/day for at least 1 year with CO > 10ppm, desiring to quit. Excludes those with serious medical conditions, hypertension, heart disease, or recent use of other cessation aids.
04
Endpoints
Primary
Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 1
Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 3
Secondary
Number of Participants Completing the Continuous 4 Week Abstinence From Smoking
Percentage of Change of CO at End of Week 1 When Comparing Abstinent Smokers Versus Non-abstinent Smokers
Percentage of Change of CO at End of Week 3 When Comparing Abstinent Smokers Versus Non-abstinent Smokers
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