NCT00965263

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2003

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2009

Completed
8.3 years until next milestone

Results Posted

Study results publicly available

December 11, 2017

Completed
Last Updated

December 11, 2017

Status Verified

September 1, 2017

Enrollment Period

6.3 years

First QC Date

August 24, 2009

Results QC Date

August 3, 2017

Last Update Submit

November 6, 2017

Conditions

Cocaine Dependence

Keywords

Cocaineimmunotherapyvaccinationantibodyaddictiondependence

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Cocaine Cardiovascular Effects

    13 weeks

  • Plasma Cocaine

    13 weeks

Study Arms (2)

Low dose Vaccine

EXPERIMENTAL

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

Biological: Cocaine vaccine (TA-CD)

High Dose Vaccine

EXPERIMENTAL

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

Biological: Cocaine vaccine (TA-CD)

Interventions

Cocaine vaccine (TA-CD)BIOLOGICAL

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

High Dose VaccineLow dose Vaccine

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York-Presbyterian Hospital

New York, New York, 10032, United States

Location

Related Publications (1)

  • 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.

    PMID: 19846066DERIVED

MeSH Terms

Conditions

Cocaine-Related DisordersBehavior, Addictive

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersCompulsive BehaviorImpulsive BehaviorBehavior

Limitations and Caveats

There was no placebo TA-CD condition, due to the substantial study demands.

Results Point of Contact

Title
Margaret Haney, Ph.D.
Organization
New York State Psychiatric Institute at Columbia University Medical Center
meg.haney@nyspi.columbia.edu
6467746153

Study Officials

  • Margaret Haney, Ph.D.

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2009

First Posted

August 25, 2009

Study Start

March 1, 2003

Primary Completion

July 1, 2009

Study Completion

August 1, 2009

Last Updated

December 11, 2017

Results First Posted

December 11, 2017

Record last verified: 2017-09

Locations

US(1)