Improving the Efficacy of Anti-Nicotine Immunotherapy

PHASE2CompletedINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

December 31, 2010

Primary Completion Date

September 30, 2012

Study Completion Date

April 30, 2013

Conditions
Nicotine Dependence
Interventions
BIOLOGICAL

NIC002 in Aluminum hydroxide (Alum)

Fifty-five subjects will receive 4 subcutaneous injections of 0.1 mg Nicotine-QB (NIC002) in Alum vaccine with a 4-week interval between injections.

BIOLOGICAL

Placebo Vaccine - Aluminum hydroxide

Ten subjects will receive 4 subcutaneous injections of indistinguishable placebo (Alum alone) with a 4-week interval between injections.

Trial Locations (2)

27157

Wake Forest University Health Sciences, Winston-Salem

27705

Duke Center for Nicotine & Smoking Cessation Research, Durham

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Wake Forest University Health Sciences

OTHER

collaborator

Novartis Pharmaceuticals

INDUSTRY

lead

Alexey Mukhin

OTHER