A Safety and Cognitive Function Study of EVP-6124 Versus Placebo in Subjects With Nicotine Dependence

Summary

This study is designed to evaluate the initial evidence for efficacy of the investigational medicine, EVP-6124, to improve smoking cessation outcomes with and without a standard taper of nicotine replacement therapy (NRT) in healthy nicotine dependent smokers

Conditions

• Nicotine Dependence
• Smoking Cessation

Interventions

DRUG

EVP-6124

One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)

DRUG

Placebo Capsule

One placebo capsule ingested orally daily for 12 weeks (84 days)

DRUG

NicoDerm Patch (Active)

One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).

DRUG

NRT Patch (Placebo)

One NRT patch (Placebo) daily for first 6 weeks (42 days).

BEHAVIORAL

Brief Supportive and Behavioral Treatment

Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.

Sponsors & Collaborators

• FORUM Pharmaceuticals Inc

  collaborator INDUSTRY

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• A. Eden Evins

  lead OTHER

Principal Investigators

• Anne Eden Evins, MD, MPH · Massachusetts General Hospital

• Maurizio Fava, MD · Massachusetts General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-12-31

Primary Completion

2015-09-30

Completion

2015-09-30

Countries

• United States

Study Locations