Nalmefene Smoking Cessation Study

Phase 2

Completed

• Conditions: Smoking Cessation
• Interventions: Drug: nalmefene; Other: Placebo

• Registration Number: NCT00202696
• Lead Sponsor: Somaxon Pharmaceuticals

Brief 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.

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Primary Completion: 2006-03
• Study Completion: 2006-03
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-15
• Last Update Posted: 2008-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• Smokers in good general health self reporting more than 15 cigarettes per day

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	nalmefene	Nalmefene 80 mg
3	Placebo	Placebo
1	nalmefene	Nalmefene 40 mg

Primary Outcome Measures

Name	Time	Method
Assess the efficacy of 2 doses of nalmefene relative to placebo

Secondary Outcome Measures

Name	Time	Method
Evaluate the safety and tolerability of 2 doses of nalmefene

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States