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Nalmefene Smoking Cessation Study

NCT00202696 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2008-05-19

No results posted yet for this study

Summary

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

Conditions

  • Smoking Cessation

Interventions

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).

OTHER

Placebo

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

Sponsors & Collaborators

  • Somaxon Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Philip Jochelson, MD · Somaxon Pharmaceuticals CMO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2006-03-31
Completion
2006-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00202696 on ClinicalTrials.gov