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Maintenance Therapy for Nicotine Dependence
NCT01047527Phase 4
Key facts
- Status
- Completed
- Start
- Jun 2009
- Primary completion
- Apr 2014
- Countries
- 1
- Sponsor
- University of Pennsylvania
- Modality
- Transdermal Patches, Small Molecules
- Drugs
- nicotine patch
- Conditions
- nicotine dependence
01
Overview
Phase 4, randomised, open-label trial of nicotine patch in nicotine dependence (3 arms), sponsored by University of Pennsylvania. Primary endpoint: Point Prevalence Abstinence at 52 weeks. Started Jun 2009; status: completed.
02
Design
3 arms- Study design
- RandomizedOpen-label
8 weeks transdermal nicotine
Standard duration therapy
24 weeks transdermal nicotine
Extended duration therapy
52 weeks transdermal nicotine
Maintenance duration therapy
03
Who it enrols
Adult smokers (>10 cigs/day) residing in the area for >12 months. Excludes psychosis, manic depression, recent heart attack, and pregnancy.
04
Endpoints
Primary
Point Prevalence Abstinence
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