Nalmefene Smoking Cessation Study - Full Text View

Sponsored by:	Somaxon Pharmaceuticals
Information provided by:	Somaxon Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00202696

Purpose

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

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

MedlinePlus related topics: Quitting Smoking Smoking

Drug Information available for: Morphinan-3,14-diol, 17-(cyclopropylmethyl)-4,5-epoxy-6-methylene-, hydrochloride, (5alpha)- Nalmefene

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Single Center Evaluation of Nalmefene HCl Versus Placebo on Smoking Cessation

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
1: Experimental 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).
2: Experimental 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

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

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

Study placed in the following topic categories:

Smoking
Nalmefene

Additional relevant MeSH terms:

Habits
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs

Narcotic Antagonists
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009