Nalmefene Smoking Cessation Study

Somaxon Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Smoking Cessation

Treatments: Other: Placebo; Drug: nalmefene

Study type: Interventional

Funder types: Industry

Identifiers

NCT00202696

SP-N0408

Details and patient eligibility

About

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

Full 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.

Enrollment: 76 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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76 participants in 3 patient groups

1

Experimental group

Description:

Nalmefene 40 mg

Treatment:

Drug: nalmefene

2

Experimental group

Description:

Nalmefene 80 mg

Treatment:

Drug: nalmefene

3

Other group

Description:

Placebo

Treatment:

Other: Placebo