Nalmefene Smoking Cessation Study

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00202696

Enrollment

Registered

2005-09-20

Start date

2005-09-30

Completion date

2006-03-31

Last updated

2008-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

Brief summary

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

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.

Interventions

DRUGnalmefene

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).

OTHERPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

25 Years to 65 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

Design outcomes

Primary

Measure	Time frame
Assess the efficacy of 2 doses of nalmefene relative to placebo	—

Secondary

Measure	Time frame
Evaluate the safety and tolerability of 2 doses of nalmefene	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026