NCT01480232 - A Safety and Cognitive Function Study of EVP-6124 Versus Placebo in Subjects With Nicotine Dependence | Biotech Hunter

Enrollment

345

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

September 30, 2015

Study Completion Date

September 30, 2015

Conditions

Nicotine DependenceSmoking 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.

Trial Locations (1)

02114

Massachusetts General Hospital, Boston