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OpenTrials
Completed

NCT Number: NCT00202696

Nalmefene Smoking Cessation Study

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

Completed

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Nalmefene

Drug

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).

Placebo

Other

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

Primary outcomes

  1. Assess the efficacy of 2 doses of nalmefene relative to placebo

Secondary outcomes

  1. Evaluate the safety and tolerability of 2 doses of nalmefene

Sponsors and collaborators

Lead sponsor

Somaxon Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 20, 2005
Registry last updated
May 19, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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