Therapeutic Cocaine Vaccine: Human Laboratory Study

Study Overview
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Brief Summary
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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
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I do not desire to provide a more extensive description.

Official Title
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Tests of a Therapeutic Cocaine Vaccine

Conditions
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Cocaine Dependence

Intervention / Treatment
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* Biological: Cocaine vaccine (TA-CD)


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cocaine, immunotherapy, vaccination, antibody, addiction, dependence