Multisite Controlled Trial of Cocaine Vaccine (TA-CD)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
US Department of Veterans Affairs Cooperative Studies Program
VA Maryland Health Care System
Columbia University
VA New York Harbor Healthcare System
University of Pennsylvania
Johns Hopkins University
University of Cincinnati
Celtic Pharma Development Services
Information provided by (Responsible Party):
Thomas R. Kosten, MD, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00969878
First received: August 31, 2009
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Cocaine Dependence
Drug: TA-CD Vaccination
Other: Placebo Injection
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study to Assess the Clinical Efficacy, Safety, and Immunogenicity of a Human Cocaine Vaccine (TA-CD) in the Treatment of Cocaine Dependence

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • The effect of TA-CD 400 µg compared to placebo on cocaine dependence over 8 weeks (Weeks 9 to 16 inclusive) [ Time Frame: Over 8 weeks ( Study Weeks 9 to 16 inclusive) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • •The immunogenicity of TA-CD; and change in levels of cocaine use and antibody levels;•The safety and tolerability of TA-CD, based on clinician observation, laboratory findings,Etc. [ Time Frame: During the 18 weeks study period. and a follow-up safety visit: week 24 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: August 2010
Estimated Study Completion Date: July 2014
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo injection
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
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.
Other Name: An aluminium hydroxide gel adjuvant in a saline solution.
Experimental: TA-CD Vaccination
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
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.
Other Name: A protein conjugate adsorbed onto aluminium hydroxide gel adjuvant in a saline solution.

Detailed Description:

This 18-week, placebo-controlled randomized clinical trial among 300 cocaine dependent patients is designed to test the efficacy of a newly developed active vaccine against cocaine (TA-CD). TA-CD vaccine consists of succinylnorcocaine (SNC) coupled to a recombinant cholera toxin B subunit (rCTB) and is designed to raise anti-cocaine antibodies in the circulation to bind to cocaine entering the bloodstream, following administration by intravenous or intranasal routes or by smoking. The antigen-antibody complexes will be too large to cross the blood-brain barrier, preventing high concentrations of cocaine reaching the brain's nucleus accumbens thereby blocking the pleasurable response to cocaine and reducing rates of drug use. The effectiveness of the vaccine is dependent on inducing sufficient levels of anti-cocaine antibodies to match the challenge from a subsequent dose of cocaine.

Because TA-CD takes several weeks to generate an antibody response, we plan to use contingency management in this interval to sustain treatment engagement. Furthermore, since TA-CD may prove most effective in patients where the antibodies can prevent a cocaine slip from turning into a binge (or return to regular use) by attenuating the priming effect, we are complementing the vaccine by using cognitive behavioral therapy (CBT) to teach patients how to cope with this priming effect and prevent a full relapse.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • (1) 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; (2) Meets DSM-IV-TR criteria for a principal diagnosis of cocaine dependence as confirmed by the MINI; (4) 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; (5) In good general health as determined by medical history, general clinical examination, laboratory tests; (6) Has provided written informed consent. Subjects should be cooperative, willing and able to participate and adhere to the Protocol requirements.

Exclusion Criteria:

  • (1) Subject is cocaine-free (i.e., negative urine results [BE level]) during the 2-week screening period. (2) 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; (3) 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; (4) 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; (5) 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. (6) 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; (7) Subject requiring medical detox for alcohol dependence (8) History of sensitivity to aluminium hydroxide gel; (9) History of severe adverse reaction to cholera vaccine; (10) Subject had previous vaccination with TA-CD; (11) Subject received other vaccines, including flu vaccine, within 14 days prior to signing consent; (12) Subject has participated in another clinical trial or received any other investigational compound within 14 days prior to signing consent; (13) Subject has received blood or blood products within the 3 months prior to signing consent; (14) Subject has liver function tests greater than 3 times the upper limit of normal at Screening; (15) Subject has systolic blood pressure higher than 140 mmHg and/or diastolic blood pressure >90 mmHg. (16) Female subjects with a positive pregnancy test, lactating mothers, women refusing to agree to adequate contraception and pregnancy tests during the study, or women who are planning to become pregnant during the period of the trial. Acceptable contraceptive methods are oral or parenteral hormonal contraceptives, intrauterine device (IUD), or barrier and spermicide, but not abstinence; (17) Male subjects refusing to agree to adequate contraception during the study, or males who are part of a couple planning to become pregnant during the period of the trial; (18) People who are involuntarily detained in a penal institution or people who become involuntarily detained during the study; (19) Any other factor that in the opinion of the Investigator or designee would make the subject unsafe or unsuitable for the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00969878

Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21224
United States, New York
Substance Abuse Treatment and Research Service (Downtown)
New York, New York, United States, 10032
NYU Langone Medical Center
New york, New York, United States, 10010
United States, Ohio
Cincinnati Addiction Research Center
Cincinnati, Ohio, United States, 45220
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
US Department of Veterans Affairs Cooperative Studies Program
VA Maryland Health Care System
Columbia University
VA New York Harbor Healthcare System
University of Pennsylvania
Johns Hopkins University
University of Cincinnati
Celtic Pharma Development Services
Investigators
Principal Investigator: Thomas R Kosten, M.D. Baylor College of Medicine
  More Information

No publications provided by Baylor College of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas R. Kosten, MD, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00969878     History of Changes
Other Study ID Numbers: R01DA025223, R01DA025223, DPMC
Study First Received: August 31, 2009
Last Updated: January 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Baylor College of Medicine:
Cocaine Vaccine, TA-CD 09

Additional relevant MeSH terms:
Cocaine-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Aluminum Hydroxide
Cocaine
Pharmaceutical Solutions
Adjuvants, Immunologic
Anesthetics
Anesthetics, Local
Antacids
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Uptake Inhibitors
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on October 20, 2014