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Nalmefene Smoking Cessation Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00202696
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : May 19, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
To determine if nalmefene is safe and effective in smoking cessation.

Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: nalmefene Other: Placebo Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Single Center Evaluation of Nalmefene HCl Versus Placebo on Smoking Cessation
Study Start Date : September 2005
Primary Completion Date : March 2006
Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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).
3
Placebo
Other: Placebo
Placebo tablets, administered orally, twice daily for 5 weeks (following a 2-week titration period).


Outcome Measures

Primary Outcome Measures :
  1. Assess the efficacy of 2 doses of nalmefene relative to placebo

Secondary Outcome Measures :
  1. Evaluate the safety and tolerability of 2 doses of nalmefene

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00202696


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Somaxon Pharmaceuticals
Investigators
Study Director: Philip Jochelson, MD Somaxon Pharmaceuticals CMO
More Information

Responsible Party: Somaxon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00202696     History of Changes
Other Study ID Numbers: SP-N0408
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: May 19, 2008
Last Verified: May 2008

Additional relevant MeSH terms:
Nalmefene
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents