Nalmefene Smoking Cessation Study

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00202696
• Other study ID #: SP-N0408
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: May 15, 2008
• Start date: September 2005
• Est. completion date: March 2006

Study information

• Verified date: May 2008
• Source: Somaxon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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).

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Somaxon Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the efficacy of 2 doses of nalmefene relative to placebo
Secondary	Evaluate the safety and tolerability of 2 doses of nalmefene