Nalmefene Smoking Cessation Study

This study has been completed.
Sponsor:
Information provided by:
Somaxon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00202696
First received: September 12, 2005
Last updated: May 15, 2008
Last verified: May 2008
  Purpose

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


Condition Intervention Phase
Smoking Cessation
Drug: nalmefene
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Single Center Evaluation of Nalmefene HCl Versus Placebo on Smoking Cessation

Resource links provided by NLM:


Further study details as provided by Somaxon Pharmaceuticals:

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

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

Enrollment: 76
Study Start Date: September 2005
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Somaxon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00202696     History of Changes
Other Study ID Numbers: SP-N0408
Study First Received: September 12, 2005
Last Updated: May 15, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Nalmefene
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014