Nalmefene Smoking Cessation Study
Information source: Somaxon Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Smoking Cessation
Intervention: nalmefene (Drug); Placebo (Other)
Phase: Phase 2
Status: Completed
Sponsored by: Somaxon Pharmaceuticals Official(s) and/or principal investigator(s): Philip Jochelson, MD, Study Director, Affiliation: Somaxon Pharmaceuticals CMO
Summary
To determine if nalmefene is safe and effective in smoking cessation.
Clinical Details
Official title: A Single Center Evaluation of Nalmefene HCl Versus Placebo on Smoking Cessation
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Assess the efficacy of 2 doses of nalmefene relative to placebo
Secondary outcome: Evaluate the safety and tolerability of 2 doses of nalmefene
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
Minimum age: 25 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Smokers in good general health self reporting more than 15 cigarettes per day
Exclusion Criteria:
-
Locations and Contacts
Mayo Clinic, Rochester, Minnesota 55905, United States
Additional Information
Starting date: September 2005
Last updated: May 15, 2008
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