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Completed

NCT Number: NCT00965263

Therapeutic Cocaine Vaccine: Human Laboratory Study

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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Key information

Conditions

Cocaine Dependence Behavior Behavior, Addictive Chemically-Induced Disorders Cocaine-Related Disorders Compulsive Behavior Impulsive Behavior Mental Disorders Substance-Related Disorders

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

New York-Presbyterian Hospital

New York, 10032, United States

About this study

I do not desire to provide a more extensive description.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

Cocaine vaccine (TA-CD)

Biological

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

Primary outcomes

  1. Cocaine Intoxication

    Time frame: 13 weeks

    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.

Secondary outcomes

  1. Cocaine Cardiovascular Effects

    Time frame: 13 weeks

    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.

  2. Plasma Cocaine

    Time frame: 13 weeks

    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.

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Registry information

Official study title

Tests of a Therapeutic Cocaine Vaccine

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Aug 25, 2009
Registry last updated
Dec 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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