Therapeutic Cocaine Vaccine: Human Laboratory Study

Cocaine Dependence Clinical Trial

Official title:

Tests of a Therapeutic Cocaine Vaccine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00965263
• Other study ID #: #3980
• Secondary ID: NIDA 1U19DA10946
• Status: Completed
• Phase: Phase 2
• First received: August 24, 2009
• Last updated: November 6, 2017
• Start date: March 2003
• Est. completion date: August 2009

Study information

• Verified date: September 2017
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

I do not desire to provide a more extensive description.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 45 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Cocaine Dependence
• Cocaine-Related Disorders

Intervention

Biological:
• Cocaine vaccine (TA-CD)
TA-CD (82,360 µg; IM) were administered at weeks 1, 3, 5 and 9.

Locations

Country	Name	City	State
United States	New York-Presbyterian Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	13 weeks
Secondary	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.	13 weeks
Secondary	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.	13 weeks