NCT00202696

Nalmefene Smoking Cessation Study

A Single Center Evaluation of Nalmefene HCl Versus Placebo on Smoking Cessation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Somaxon Pharmaceuticals · Industry
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To determine if nalmefene is safe and effective in smoking cessation.

Detailed description

Single centered, randomized, placebo-controlled,double-blind, outpatient pilot study to evaluate the efficacy, safety and tolerability of 2 doses of nalmefene on smoking cessation.

Conditions

• Smoking Cessation

Interventions

Type	Name	Description
DRUG	nalmefene	Nalmefene HCl film-coated tablets administered orally, twice daily, for total daily dosage of 40 or 80 mg, for 5 weeks (following a 2-week titration period).
OTHER	Placebo	Placebo tablets, administered orally, twice daily for 5 weeks (following a 2-week titration period).

Timeline

• Start date: 2005-09-01
• Primary completion: 2006-03-01
• Completion: 2006-03-01
• First posted: 2005-09-20
• Last updated: 2008-05-19

Locations

1 site across 1 country: United States