Effectiveness of TA-CD Vaccine in Treating Cocaine Dependent Individuals

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00142857
First received: September 1, 2005
Last updated: February 19, 2008
Last verified: February 2008

September 1, 2005
February 19, 2008
July 2003
June 2006   (final data collection date for primary outcome measure)
Number of methadone maintained individuals who achieve 3 consecutive weeks of cocaine abstinence between Weeks 8 and 20
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Complete list of historical versions of study NCT00142857 on ClinicalTrials.gov Archive Site
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Effectiveness of TA-CD Vaccine in Treating Cocaine Dependent Individuals
Cocaine Vaccine for Methadone Maintained Patients

Cocaine dependence is a major public health problem; an effective treatment for cocaine dependent individuals has yet to be found. The purpose of this study is to evaluate the effectiveness of the cocaine vaccine candidate TA-CD in treating cocaine dependent individuals.

Cocaine is a highly addictive stimulant that has high abuse potential. An effective drug to treat cocaine dependent individuals has yet to be found. Cocaine produces euphoric effects by blocking the re-uptake of neurotransmitters, such as dopamine, within the brain. The vaccine candidate TA-CD is a cocaine derivative coupled to recombinant cholera toxin B. It is designed to generate drug-specific antibodies that bind to cocaine and prevent it from travelling to the brain from the blood, thereby neutralizing its psychoaffective effect. The purpose of this study is to evaluate the effectiveness of TA-CD versus placebo in treating cocaine dependent individuals.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cocaine-Related Disorders
  • Biological: TA-CD
  • Drug: placebo
  • Experimental: 1
    TACD
    Intervention: Biological: TA-CD
  • Placebo Comparator: 2
    Intervention: Drug: placebo
Martell BA, Orson FM, Poling J, Mitchell E, Rossen RD, Gardner T, Kosten TR. Cocaine vaccine for the treatment of cocaine dependence in methadone-maintained patients: a randomized, double-blind, placebo-controlled efficacy trial. Arch Gen Psychiatry. 2009 Oct;66(10):1116-23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
125
June 2006
June 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Moderate to severe cocaine or opioid dependence
  • Willing to enroll in methadone maintenance treatment
  • Demonstrates motivation to stop using cocaine
  • In good general health
  • If female, willing to use an adequate form of contraception for the duration of the study

Exclusion Criteria:

  • Currently suicidal or experiencing psychosis
  • History of psychosis or schizophrenia
  • Inability to read or understand English
  • Current dependence on drugs or alcohol other than cocaine, opiates, or tobacco
  • History of uveitis or ocular abnormalities associated with uveitis
  • Any concomitant disease or abnormalities that, in the opinion of the investigator, may interfere with the study
  • Requires psychotropic medications or steroids within 30 days of study entry
  • Immune deficiency
  • Ongoing active infection
  • HIV infected
  • Pregnant
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00142857
NIDA-15477-1, R01-15477-1, DPMC
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Not Provided
National Institute on Drug Abuse (NIDA)
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Principal Investigator: Thomas R. Kosten, MD Yale University, Department of Psychiatry
National Institute on Drug Abuse (NIDA)
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP