Multisite Controlled Trial of Cocaine Vaccine (TA-CD)

This study has been completed.
Sponsor:
Collaborators:
US Department of Veterans Affairs Cooperative Studies Program
VA Maryland Health Care System
Columbia University
VA New York Harbor Healthcare System
University of Pennsylvania
Johns Hopkins University
University of Cincinnati
Celtic Pharma Development Services
Information provided by (Responsible Party):
Thomas R. Kosten, MD, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00969878
First received: August 31, 2009
Last updated: December 11, 2014
Last verified: December 2014
Results First Received: July 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Cocaine Dependence
Interventions: Drug: TA-CD Vaccination
Other: Placebo Injection

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo Injection

TA-CD placebo will be administered intra muscular. A total of 5 injections will be given over 12 weeks (i.e., at Day 1 and at the beginning of Weeks 3, 5, 9 and 13).

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.

TA-CD Vaccination

TA-CD 400 μg will be administered intramuscular. A total of 5 injections will be given over 12 weeks (i.e., at Day 1 and at the beginning of Weeks 3, 5, 9 and 13).

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.


Participant Flow:   Overall Study
    Placebo Injection     TA-CD Vaccination  
STARTED     148     152  
COMPLETED     118     126  
NOT COMPLETED     30     26  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Placebo Injection

TA-CD placebo will be administered intra muscular. A total of 5 injections will be given over 12 weeks (i.e., at Day 1 and at the beginning of Weeks 3, 5, 9 and 13).

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.

TA-CD Vaccination

TA-CD 400 μg will be administered intramuscular. A total of 5 injections will be given over 12 weeks (i.e., at Day 1 and at the beginning of Weeks 3, 5, 9 and 13).

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.

Total Total of all reporting groups

Baseline Measures
    Placebo Injection     TA-CD Vaccination     Total  
Number of Participants  
[units: participants]
  148     152     300  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     148     152     300  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     34     38     72  
Male     114     114     228  
Region of Enrollment  
[units: participants]
     
United States     148     152     300  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Cocaine Abstinence During Weeks 9 to 16 Inclusive   [ Time Frame: Over 8 weeks ( Study Weeks 9 to 16 inclusive) ]

2.  Secondary:   •The Immunogenicity of TA-CD;   [ Time Frame: During the 18 weeks study period. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Thomas Kosten
Organization: Baylor
phone: 7137947032
e-mail: kosten@bcm.edu


No publications provided by Baylor College of Medicine

Publications automatically indexed to this study:

Responsible Party: Thomas R. Kosten, MD, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00969878     History of Changes
Other Study ID Numbers: R01DA025223, R01DA025223, DPMC
Study First Received: August 31, 2009
Results First Received: July 17, 2014
Last Updated: December 11, 2014
Health Authority: United States: Food and Drug Administration