Back to resultsTherapeutic Cocaine Vaccine: Human Laboratory Study
Primary Purpose
Cocaine Dependence
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cocaine vaccine (TA-CD)
Sponsored by
About this trial
This is an interventional treatment trial for Cocaine Dependence focused on measuring Cocaine, immunotherapy, vaccination, antibody, addiction, dependence
Eligibility Criteria
Inclusion Criteria:
- Meets DSM-IV criteria for current cocaine dependence. The volunteer may meet criteria for other substance abuse, but not dependence (other than nicotine).
- Primary route of cocaine administration is smoking.
- Age 21-45.
- Females must be surgically sterilized or post- menopausal
- Able to give informed consent, and comply with study procedures.
Exclusion Criteria:
- Dependence on substances other than cocaine or nicotine.
- Judged to be noncompliant with study protocol.
- History of autoimmune disease, immune deficiency or hypersensitivity to other vaccines. An HIV test must be negative.
- Currently uses drugs intravenously
- Currently taking any psychotropic medication
- 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)
- Blood or blood products given in the three months prior to vaccination
- Other vaccines, including flu vaccine, given within 30 days of screening.
- Ongoing active infection
- Currently taking immunosuppressives -
Sites / Locations
- New York-Presbyterian Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Low dose Vaccine
High Dose Vaccine
Arm Description
All participants were vaccinated four times: in week 1, 3, 5, and 9. Dose: 82ul
All participants were vaccinated four times: in week 1, 3, 5, and 9. Dose: 360ul
Outcomes
Primary Outcome Measures
Cocaine Intoxication
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
Cocaine Cardiovascular Effects
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.
Plasma Cocaine
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.
Full Information
NCT ID
NCT00965263
First Posted
August 24, 2009
Last Updated
November 6, 2017
Sponsor
New York State Psychiatric Institute
1. Study Identification
Unique Protocol Identification Number
NCT00965263
Brief Title
Therapeutic Cocaine Vaccine: Human Laboratory Study
Official Title
Tests of a Therapeutic Cocaine Vaccine
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
I do not desire to provide a more extensive description.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence
Keywords
Cocaine, immunotherapy, vaccination, antibody, addiction, dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low dose Vaccine
Arm Type
Experimental
Arm Description
All participants were vaccinated four times: in week 1, 3, 5, and 9. Dose: 82ul
Arm Title
High Dose Vaccine
Arm Type
Experimental
Arm Description
All participants were vaccinated four times: in week 1, 3, 5, and 9. Dose: 360ul
Intervention Type
Biological
Intervention Name(s)
Cocaine vaccine (TA-CD)
Intervention Description
TA-CD (82,360 μg; IM) were administered at weeks 1, 3, 5 and 9.
Primary Outcome Measure Information:
Title
Cocaine Intoxication
Description
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.
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
Cocaine Cardiovascular Effects
Description
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.
Time Frame
13 weeks
Title
Plasma Cocaine
Description
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.
Time Frame
13 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Meets DSM-IV criteria for current cocaine dependence. The volunteer may meet criteria for other substance abuse, but not dependence (other than nicotine).
Primary route of cocaine administration is smoking.
Age 21-45.
Females must be surgically sterilized or post- menopausal
Able to give informed consent, and comply with study procedures.
Exclusion Criteria:
Dependence on substances other than cocaine or nicotine.
Judged to be noncompliant with study protocol.
History of autoimmune disease, immune deficiency or hypersensitivity to other vaccines. An HIV test must be negative.
Currently uses drugs intravenously
Currently taking any psychotropic medication
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)
Blood or blood products given in the three months prior to vaccination
Other vaccines, including flu vaccine, given within 30 days of screening.
Ongoing active infection
Currently taking immunosuppressives -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret Haney, Ph.D.
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York-Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19846066
Citation
Haney M, Gunderson EW, Jiang H, Collins ED, Foltin RW. Cocaine-specific antibodies blunt the subjective effects of smoked cocaine in humans. Biol Psychiatry. 2010 Jan 1;67(1):59-65. doi: 10.1016/j.biopsych.2009.08.031.
Results Reference
derived
Learn more about this trial
Therapeutic Cocaine Vaccine: Human Laboratory Study
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