300
Participants
Start Date
August 31, 2010
Primary Completion Date
August 31, 2012
Study Completion Date
July 31, 2014
TA-CD Vaccination
On Day 1, subjects will be randomized to receive vaccination. Day 1 to Week 16 (3 visits per week) Subsequent vaccinations will be administered at the beginning of Weeks 3, 5, 9 and 13. There should be at least 10 days between vaccinations. Three times per week visits will be scheduled during this period through Week 16. The assessments for the active phase will be scheduled. Therapy sessions will be provided by a qualified professional such as a master's level counselor.
Placebo Injection
On Day 1, subjects will be randomized to receive placebo injection. Day 1 to Week 16 (3 visits per week) Subsequent placebo injections will be administered at the beginning of Weeks 3, 5, 9 and 13. There should be at least 10 days between injections. Three times per week visits will be scheduled during this period through Week 16. The assessments for the efficacy and safety monitor will be scheduled.Therapy sessions will be provided by a qualified professional such as a master's level counselor.
NYU Langone Medical Center, New York
Substance Abuse Treatment and Research Service (Downtown), New York
University of Pennsylvania, Philadelphia
Johns Hopkins University, Baltimore
Cincinnati Addiction Research Center, Cincinnati
Baylor College of Medicine, Houston
Collaborators (1)
National Institute on Drug Abuse (NIDA)
NIH
US Department of Veterans Affairs Cooperative Studies Program
NETWORK
VA Maryland Health Care System
FED
Columbia University
OTHER
VA New York Harbor Healthcare System
FED
University of Pennsylvania
OTHER
Johns Hopkins University
OTHER
University of Cincinnati
OTHER
Celtic Pharma Development Services
INDUSTRY
Baylor College of Medicine
OTHER