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Therapeutic Cocaine Vaccine: Human Laboratory Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00965263
First received: August 24, 2009
Last updated: January 29, 2013
Last verified: January 2013
History of Changes
  Purpose

Clinical data demonstrate that a cocaine vaccine (TA-CD: Celtic Pharmaceutical) produces selective anti-cocaine antibodies, yet the impact of these antibodies on cocaine's direct effects is unknown. The objective of this human laboratory study was to measure the relationship between antibody titers and the effects of smoked cocaine on ratings of intoxication, craving and cardiovascular effects.

Cocaine-dependent volunteers not seeking drug treatment spend 2 nights per week for 13 weeks inpatient where the effects of cocaine (0, 25, 50 mg) are determined prior to vaccination and at weekly intervals thereafter. Vaccinations occur at weeks 1, 3, 5 and 9.


Condition Intervention Phase
Cocaine Dependence
 Biological: TA-CD
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Tests of a Therapeutic Cocaine Vaccine

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Cocaine intoxication [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cocaine cardiovascular effects [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: March 2003
Study Completion Date: August 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaccine
All subjects received 4 active vaccinations with TA-CD
 Biological: TA-CD
TA-CD (82,360 μg; IM) were administered at weeks 1, 3, 5 and 9.

Detailed Description:

I do not desire to provide a more extensive description.

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Meets DSM-IV criteria for current cocaine dependence. The volunteer may meet criteria for other substance abuse, but not dependence (other than nicotine).
  2. Primary route of cocaine administration is smoking.
  3. Age 21-45.
  4. Females must be surgically sterilized or post- menopausal
  5. Able to give informed consent, and comply with study procedures.

Exclusion Criteria:

  1. Dependence on substances other than cocaine or nicotine.
  2. Judged to be noncompliant with study protocol.
  3. History of autoimmune disease, immune deficiency or hypersensitivity to other vaccines. An HIV test must be negative.
  4. Currently uses drugs intravenously
  5. Currently taking any psychotropic medication
  6. Laboratory tests that are clinically unacceptable to the study physician (BP > 140/90; BUN, creatinine, LFTs > 1.5 ULN; hematocrit < 34 for women, < 36 for men)
  7. Blood or blood products given in the three months prior to vaccination
  8. Other vaccines, including flu vaccine, given within 30 days of screening.
  9. Ongoing active infection
  10. Currently taking immunosuppressives -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00965263

Locations
United States, New York
New York-Presbyterian Hospital
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Margaret Haney, Ph.D. Columbia University
  More Information

No publications provided by New York State Psychiatric Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00965263     History of Changes
Other Study ID Numbers: #3980, NIDA 1U19DA10946
Study First Received: August 24, 2009
Last Updated: January 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by New York State Psychiatric Institute:
Cocaine
immunotherapy
vaccination
 antibody
addiction
dependence

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Mental Disorders
Cocaine
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013