Therapeutic Cocaine Vaccine: Human Laboratory Study

Tests of a Therapeutic Cocaine Vaccine

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.

Study Overview

• Status: Completed
• Conditions: Cocaine Dependence
• Intervention / Treatment: Biological: Cocaine vaccine (TA-CD)

Detailed Description

I do not desire to provide a more extensive description.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • New York-Presbyterian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute
• Investigators: Principal Investigator: Margaret Haney, Ph.D., Columbia University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2003
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: August 24, 2009
• First Submitted That Met QC Criteria: August 24, 2009
• First Posted (Estimate): August 25, 2009

Study Record Updates

• Last Update Posted (Actual): December 11, 2017
• Last Update Submitted That Met QC Criteria: November 6, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: addiction; immunotherapy; antibody; vaccination; Cocaine; dependence
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Cocaine-Related Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Anesthetics, Local; Dopamine Uptake Inhibitors; Vasoconstrictor Agents; Cocaine
• Other Study ID Numbers: #3980; NIDA 1U19DA10946