Multisite Controlled Trial of Cocaine Vaccine
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Intervention: TA-CD Vaccination; Placebo Injection
Intervention description: 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.
Intervention MeSH terms: Aluminum Hydroxide; Pharmaceutical Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 300.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Cocaine Vaccine, TA-CD 09

Summary:

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

Eligibility criteria:

        INCLUSION CRITERIA:

          1. Male or female. Females either must be of non-child bearing potential (i.e.,
             surgically sterilized or postmenopausal) or must be using adequate contraception, have
             a negative pregnancy test, and must agree to continue to use such precautions for 3
             months after the last vaccination;

          2. Meets DSM-IV-TR criteria for a principal diagnosis of cocaine dependence as confirmed
             by the MINI;

          3. Motivated to discontinue or reduce cocaine use during the period of the study as
             evidenced both by the judgment of the Investigator or designee and by the subject
             providing at least 2 urine samples in each of the 2 baseline weeks;

          4. In good general health as determined by medical history, general clinical examination,
             laboratory tests;

          5. Has provided written informed consent. Subjects should be cooperative, willing and
             able to participate and adhere to the Protocol requirements.

        EXCLUSION CRITERIA:

          1. Subject is cocaine-free (i.e., negative urine results [BE level]) during the 2-week
             screening period;

          2. Subject has known immunodeficiency or has a history of autoimmune disease or
             hypersensitivity to other vaccines. A human immunodeficiency virus (HIV) test must be
             performed at Screening and reported as negative for HIV-1 and HIV-2;

          3. Currently taking medication known to have significant immunosuppressive effects such
             as systemic glucocorticoids (topical and inhaled formulations are permitted) or oral
             systemic corticosteroids, within 30 days prior to randomization;

          4. Currently taking a dopaminergic, dopamine-blocking, dopamine-modulating, or other
             central dopamine-altering drug (e.g., antipsychotic drugs); a monoamine oxidase
             inhibitor (MAOI); or an opiate antagonist;

          5. Subject has an unstable medical, neurologic, or psychiatric illness that would
             interfere with the subject's safety, ability to participate in the study, or the
             interpretability of data. Subjects who meet the DSM-IV-TR criteria for psychosis,
             schizophrenia, bipolar disorder or clinically significant suicidal ideation;

          6. Subject had dependence on benzodiazepines, barbiturates, opiates or amphetamines
             according to DSM-IV-TR during the year prior to Screening. Opioid dependence includes
             methadone or buprenorphine maintenance treatment;

          7. Subject requiring medical detox for alcohol dependence;

          8. History of sensitivity to aluminium hydroxide gel;

          9. History of severe adverse reaction to cholera vaccine;

         10. Subject had previous vaccination with TA-CD;

         11. Subject received other vaccines, including flu vaccine, within 14 days prior to
             signing consent;

         12. Subject has participated in another clinical trial or received any other
             investigational compound within 14 days prior to signing consent;

         13. Subject has received blood or blood products within the 3 months prior to signing
             consent;

         14. Subject has liver function tests greater than 3 times the upper limit of normal at
             Screening;

         15. Subject has systolic blood pressure higher than 140 mmHg and/or diastolic blood
             pressure >90 mmHg;

         16. Female subjects with a positive pregnancy test, lactating mothers, women refusing to
             agree to adequate contraception and pregnancy tests during the study, or women who are
             planning to become pregnant during the period of the trial. Acceptable contraceptive
             methods are oral or parenteral hormonal contraceptives, intrauterine device (IUD), or
             barrier and spermicide, but not abstinence;

         17. Male subjects refusing to agree to adequate contraception during the study, or males
             who are part of a couple planning to become pregnant during the period of the trial;

         18. People who are involuntarily detained in a penal institution or people who become
             involuntarily detained during the study;

         19. Any other factor that in the opinion of the Investigator or designee would make the
             subject unsafe or unsuitable for the study.