Multisite Controlled Trial of Cocaine Vaccine

NCT00969878 | Completed Phase 2 Results DMC

• 2 other identifiers: R01DA025223DPMC
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to test the efficacy of a newly developed active vaccine against cocaine (TA-CD).

Conditions

Cocaine Dependence

Keywords

Cocaine Vaccine, TA-CD 09

Outcome Measures

Primary Outcomes (1)

• Cocaine Abstinence During Weeks 9 to 16 Inclusive

  Number of patients having at least 2 weeks of cocaine-free urines between weeks 9-16 after vaccination with five doses of TA-CD 400 µg compared to placebo

  Over 8 weeks ( Study Weeks 9 to 16 inclusive)

Secondary Outcomes (1)

• •The Immunogenicity of TA-CD;

  During the 18 weeks study period.

Study Arms (2)

Placebo injection

PLACEBO COMPARATOR

TA-CD placebo will be administered intra muscular. A total of 5 injections will be given over 12 weeks (i.e., at Day 1 and at the beginning of Weeks 3, 5, 9 and 13).

Other: Placebo Injection

TA-CD Vaccination

EXPERIMENTAL

TA-CD 400 μg will be administered intramuscular. A total of 5 injections will be given over 12 weeks (i.e., at Day 1 and at the beginning of Weeks 3, 5, 9 and 13).

Drug: TA-CD Vaccination

Interventions

TA-CD Vaccination DRUG

On Day 1, subjects will be randomized to receive vaccination. Day 1 to Week 16 (3 visits per week) Subsequent vaccinations will be administered at the beginning of Weeks 3, 5, 9 and 13. There should be at least 10 days between vaccinations. Three times per week visits will be scheduled during this period through Week 16. The assessments for the active phase will be scheduled. Therapy sessions will be provided by a qualified professional such as a master's level counselor.

Also known as: An aluminium hydroxide gel adjuvant in a saline solution.

TA-CD Vaccination

Placebo Injection OTHER

On Day 1, subjects will be randomized to receive placebo injection. Day 1 to Week 16 (3 visits per week) Subsequent placebo injections will be administered at the beginning of Weeks 3, 5, 9 and 13. There should be at least 10 days between injections. Three times per week visits will be scheduled during this period through Week 16. The assessments for the efficacy and safety monitor will be scheduled.Therapy sessions will be provided by a qualified professional such as a master's level counselor.

Also known as: An aluminium hydroxide gel adjuvant in a saline solution.

Placebo injection

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female. Females either must be of non-child bearing potential (i.e., surgically sterilized or postmenopausal) or must be using adequate contraception, have a negative pregnancy test, and must agree to continue to use such precautions for 3 months after the last vaccination;
• Meets DSM-IV-TR criteria for a principal diagnosis of cocaine dependence as confirmed by the MINI;
• Motivated to discontinue or reduce cocaine use during the period of the study as evidenced both by the judgment of the Investigator or designee and by the subject providing at least 2 urine samples in each of the 2 baseline weeks;
• In good general health as determined by medical history, general clinical examination, laboratory tests;
• Has provided written informed consent. Subjects should be cooperative, willing and able to participate and adhere to the Protocol requirements.

You may not qualify if:

• Subject is cocaine-free (i.e., negative urine results \[BE level\]) during the 2-week screening period;
• Subject has known immunodeficiency or has a history of autoimmune disease or hypersensitivity to other vaccines. A human immunodeficiency virus (HIV) test must be performed at Screening and reported as negative for HIV-1 and HIV-2;
• Currently taking medication known to have significant immunosuppressive effects such as systemic glucocorticoids (topical and inhaled formulations are permitted) or oral systemic corticosteroids, within 30 days prior to randomization;
• Currently taking a dopaminergic, dopamine-blocking, dopamine-modulating, or other central dopamine-altering drug (e.g., antipsychotic drugs); a monoamine oxidase inhibitor (MAOI); or an opiate antagonist;
• Subject has an unstable medical, neurologic, or psychiatric illness that would interfere with the subject's safety, ability to participate in the study, or the interpretability of data. Subjects who meet the DSM-IV-TR criteria for psychosis, schizophrenia, bipolar disorder or clinically significant suicidal ideation;
• Subject had dependence on benzodiazepines, barbiturates, opiates or amphetamines according to DSM-IV-TR during the year prior to Screening. Opioid dependence includes methadone or buprenorphine maintenance treatment;
• Subject requiring medical detox for alcohol dependence;
• History of sensitivity to aluminium hydroxide gel;
• History of severe adverse reaction to cholera vaccine;
• Subject had previous vaccination with TA-CD;
• Subject received other vaccines, including flu vaccine, within 14 days prior to signing consent;
• Subject has participated in another clinical trial or received any other investigational compound within 14 days prior to signing consent;
• Subject has received blood or blood products within the 3 months prior to signing consent;
• Subject has liver function tests greater than 3 times the upper limit of normal at Screening;
• Subject has systolic blood pressure higher than 140 mmHg and/or diastolic blood pressure \>90 mmHg;

Sponsors & Collaborators

• Baylor College of Medicine: lead
• National Institute on Drug Abuse (NIDA): collaborator
• US Department of Veterans Affairs Cooperative Studies Program: collaborator
• VA Maryland Health Care System: collaborator
• Columbia University: collaborator
• VA New York Harbor Healthcare System: collaborator
• University of Pennsylvania: collaborator
• Johns Hopkins University: collaborator
• University of Cincinnati: collaborator
• Celtic Pharma Development Services: collaborator

Study Sites (6)

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

NYU Langone Medical Center

New York, New York, 10010, United States

Location

Substance Abuse Treatment and Research Service (Downtown)

New York, New York, 10032, United States

Location

Cincinnati Addiction Research Center

Cincinnati, Ohio, 45220, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (2)

• Kosten TR, Domingo CB, Shorter D, Orson F, Green C, Somoza E, Sekerka R, Levin FR, Mariani JJ, Stitzer M, Tompkins DA, Rotrosen J, Thakkar V, Smoak B, Kampman K. Vaccine for cocaine dependence: a randomized double-blind placebo-controlled efficacy trial. Drug Alcohol Depend. 2014 Jul 1;140:42-7. doi: 10.1016/j.drugalcdep.2014.04.003. Epub 2014 Apr 16.

  PMID: 24793366 DERIVED

• Martell BA, Orson FM, Poling J, Mitchell E, Rossen RD, Gardner T, Kosten TR. Cocaine vaccine for the treatment of cocaine dependence in methadone-maintained patients: a randomized, double-blind, placebo-controlled efficacy trial. Arch Gen Psychiatry. 2009 Oct;66(10):1116-23. doi: 10.1001/archgenpsychiatry.2009.128.

  PMID: 19805702 DERIVED

MeSH Terms

Conditions

Cocaine-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Thomas Kosten
• Organization: Baylor

kosten@bcm.edu

7137947032

Study Officials

• Thomas R Kosten, M.D.

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 31, 2009
• First Posted: September 1, 2009
• Study Start: August 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: July 1, 2014
• Last Updated: March 15, 2017
• Results First Posted: December 12, 2014

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)