Nalmefene Smoking Cessation Study

May 15, 2008 updated by: Somaxon Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Nalmefene 40 mg
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).
Experimental: 2
Nalmefene 80 mg
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: 3
Placebo
Other: Placebo
Placebo tablets, administered orally, twice daily for 5 weeks (following a 2-week titration period).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Assess the efficacy of 2 doses of nalmefene relative to placebo

Secondary Outcome Measures

Outcome Measure
Evaluate the safety and tolerability of 2 doses of nalmefene

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Somaxon Pharmaceuticals

Investigators

  • Study Director: Philip Jochelson, MD, Somaxon Pharmaceuticals CMO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

May 19, 2008

Last Update Submitted That Met QC Criteria

May 15, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP-N0408

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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