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Therapeutic Cocaine Vaccine: Human Laboratory Study

NCT ID: NCT00965263

Last Updated: 2017-12-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2009-08-31

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.

Conditions

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Cocaine Dependence

Keywords

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Cocaine immunotherapy vaccination antibody addiction dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Low dose Vaccine

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

Group Type EXPERIMENTAL

Cocaine vaccine (TA-CD)

Intervention Type BIOLOGICAL

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

High Dose Vaccine

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

Group Type EXPERIMENTAL

Cocaine vaccine (TA-CD)

Intervention Type BIOLOGICAL

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

Interventions

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Cocaine vaccine (TA-CD)

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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 -
Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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New York State Psychiatric Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Margaret Haney, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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New York-Presbyterian Hospital

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 19846066 (View on PubMed)

Other Identifiers

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NIDA 1U19DA10946

Identifier Type: -

Identifier Source: secondary_id

#3980

Identifier Type: -

Identifier Source: org_study_id