Multisite Controlled Trial of Cocaine Vaccine
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test the efficacy of a newly developed active vaccine against
      cocaine (TA-CD).
    

Detailed description: 
      This 18-week, placebo-controlled randomized clinical trial among 300 cocaine dependent
      patients is designed to test the efficacy of a newly developed active vaccine against cocaine
      (TA-CD). TA-CD vaccine consists of succinylnorcocaine (SNC) coupled to a recombinant cholera
      toxin B subunit (rCTB) and is designed to raise anti-cocaine antibodies in the circulation to
      bind to cocaine entering the bloodstream, following administration by intravenous or
      intranasal routes or by smoking. The antigen-antibody complexes will be too large to cross
      the blood-brain barrier, preventing high concentrations of cocaine reaching the brain's
      nucleus accumbens thereby blocking the pleasurable response to cocaine and reducing rates of
      drug use. The effectiveness of the vaccine is dependent on inducing sufficient levels of
      anti-cocaine antibodies to match the challenge from a subsequent dose of cocaine.

      Because TA-CD takes several weeks to generate an antibody response, we plan to use
      contingency management in this interval to sustain treatment engagement. Furthermore, since
      TA-CD may prove most effective in patients where the antibodies can prevent a cocaine slip
      from turning into a binge (or return to regular use) by attenuating the priming effect, we
      are complementing the vaccine by using cognitive behavioral therapy (CBT) to teach patients
      how to cope with this priming effect and prevent a full relapse.
    

Intervention name(s): TA-CD Vaccination; Placebo Injection
Intervention type(s): Drug; Other
Intervention description(s): 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.; 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.
Other intervention name(s): An aluminium hydroxide gel adjuvant in a saline solution.; An aluminium hydroxide gel adjuvant in a saline solution.
Intervention MeSH terms: Aluminum Hydroxide; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cocaine Vaccine, TA-CD 09