Nalmefene Smoking Cessation Study

Phase 2CompletedNCT00202696

Somaxon Pharmaceuticals76 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Smoking Cessation

Interventions

nalmefeneDRUG

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).

PlaceboOTHER

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

Eligibility

Sex: ALLMin age: 25 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Smokers in good general health self reporting more than 15 cigarettes per day Exclusion Criteria: \-

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Assess the efficacy of 2 doses of nalmefene relative to placebo

Secondary Outcomes

Evaluate the safety and tolerability of 2 doses of nalmefene

Data from ClinicalTrials.gov

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