Therapeutic Cocaine Vaccine: Human Laboratory Study

New York State Psychiatric Institute15 enrolled

Overview

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.

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Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Cocaine Dependence

Interventions

Eligibility

Sex: ALLMin age: 21 YearsMax age: 45 YearsHealthy volunteers:

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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 -

Outcomes

Primary Outcomes

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.

Time frame: 13 weeks

Secondary Outcomes

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.

Time frame: 13 weeks

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.

Time frame: 13 weeks

Therapeutic Cocaine Vaccine: Human Laboratory Study

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes