ClinicalTrials.gov
ClinicalTrials.gov Menu

Therapeutic Cocaine Vaccine: Human Laboratory Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00965263
Recruitment Status : Completed
First Posted : August 25, 2009
Results First Posted : December 11, 2017
Last Update Posted : December 11, 2017
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute

Brief Summary:

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 or disease Intervention/treatment Phase
Cocaine Dependence Biological: Cocaine vaccine (TA-CD) Phase 2

Detailed Description:
I do not desire to provide a more extensive description.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Tests of a Therapeutic Cocaine Vaccine
Study Start Date : March 2003
Actual Primary Completion Date : July 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low dose Vaccine
All participants were vaccinated four times: in week 1, 3, 5, and 9. Dose: 82ul
Biological: Cocaine vaccine (TA-CD)
TA-CD (82,360 μg; IM) were administered at weeks 1, 3, 5 and 9.

Experimental: High Dose Vaccine
All participants were vaccinated four times: in week 1, 3, 5, and 9. Dose: 360ul
Biological: Cocaine vaccine (TA-CD)
TA-CD (82,360 μg; IM) were administered at weeks 1, 3, 5 and 9.




Primary Outcome Measures :
  1. Cocaine Intoxication [ Time Frame: 13 weeks ]
    Visual Analogue Scale ratings (0-100mm) of the Good Drug Effect cluster ("Good Drug Effect," "High," "Stimulated") over 13 weeks as a function of cocaine dose (25mg or 50mg). Participants (n=10) were evenly divided into High Antibody (AB) and Low Antibody (AB) groups based on their peak antibody levels at Week 13. Higher numbers indicate more agreement with the statements.


Secondary Outcome Measures :
  1. Cocaine Cardiovascular Effects [ Time Frame: 13 weeks ]
    Heart rate levels in Week 3 and Week 13 as a function of cocaine dose in High and Low antibody groups. Participants (n=10) were evenly divided into High Antibody (AB) and Low Antibody (AB) groups based on their peak antibody levels at Week 13. Higher numbers indicate higher heart rates.

  2. Plasma Cocaine [ Time Frame: 13 weeks ]
    Plasma cocaine levels in Week 3 and Week 13 as a function of cocaine dose in High and Low AB groups. Participants (n=10) were evenly divided into High Antibody (AB) and Low Antibody (AB) groups based on their peak antibody levels at Week 13. Higher numbers indicate higher plasma levels of cocaine.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: August 25, 2009    Key Record Dates
Results First Posted: December 11, 2017
Last Update Posted: December 11, 2017
Last Verified: September 2017

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

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Vaccines
Cocaine
Immunologic Factors
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents