Therapeutic Cocaine Vaccine: Human Laboratory Study

New York State Psychiatric Institute

Status and phase: Completed; Phase 2

Conditions: Cocaine Dependence

Treatments: Biological: Cocaine vaccine (TA-CD)

Study type: Interventional

Funder types: Other

Identifiers

NCT00965263

#3980

NIDA 1U19DA10946

Details and patient eligibility

About

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.

Full description

I do not desire to provide a more extensive description.

Enrollment: 15 patients

Sex: All

Ages: 21 to 45 years old

Volunteers: Accepts Healthy Volunteers

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 -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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15 participants in 2 patient groups

Low dose Vaccine

Experimental group

Description:

All participants were vaccinated four times: in week 1, 3, 5, and 9. Dose: 82ul

Treatment:

Biological: Cocaine vaccine (TA-CD)

High Dose Vaccine

Experimental group

Description:

All participants were vaccinated four times: in week 1, 3, 5, and 9. Dose: 360ul

Treatment:

Biological: Cocaine vaccine (TA-CD)