NCT01480232

A Safety and Cognitive Function Study of EVP-6124 Versus Placebo in Subjects With Nicotine Dependence

Proof-of-Concept Study of EVP-6124, an Alpha-7 Nicotinic Acetylcholine Receptor Agonist, Versus Placebo in Subjects With Nicotine Dependence

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 345 (actual)
• Sponsor: A. Eden Evins · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the initial evidence for efficacy of the investigational medicine, EVP-6124, to improve smoking cessation outcomes with and without a standard taper of nicotine replacement therapy (NRT) in healthy nicotine dependent smokers

Conditions

• Nicotine Dependence
• Smoking Cessation

Interventions

Type	Name	Description
DRUG	EVP-6124	One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)
DRUG	Placebo Capsule	One placebo capsule ingested orally daily for 12 weeks (84 days)
DRUG	NicoDerm Patch (Active)	One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).
DRUG	NRT Patch (Placebo)	One NRT patch (Placebo) daily for first 6 weeks (42 days).
BEHAVIORAL	Brief Supportive and Behavioral Treatment	Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.

Timeline

• Start date: 2011-12-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2011-11-28
• Last updated: 2017-04-06
• Results posted: 2017-04-06

Locations

1 site across 1 country: United States