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Nalmefene Smoking Cessation Study

NCT ID: NCT00202696

Last Updated: 2008-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Nalmefene 40 mg

Group Type EXPERIMENTAL

nalmefene

Intervention Type 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).

2

Nalmefene 80 mg

Group Type EXPERIMENTAL

nalmefene

Intervention Type 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).

3

Placebo

Group Type OTHER

Placebo

Intervention Type OTHER

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

Interventions

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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).

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Somaxon Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Somaxon Pharmaceuticals

Principal Investigators

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Philip Jochelson, MD

Role: STUDY_DIRECTOR

Somaxon Pharmaceuticals CMO

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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SP-N0408

Identifier Type: -

Identifier Source: org_study_id