Effectiveness of TA-CD Vaccine in Treating Cocaine Dependent Individuals - Full Text View

Sponsor:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00142857

Purpose

Cocaine dependence is a major public health problem; an effective treatment for cocaine dependent individuals has yet to be found. The purpose of this study is to evaluate the effectiveness of the cocaine vaccine candidate TA-CD in treating cocaine dependent individuals.

Condition	Intervention	Phase
Cocaine-Related Disorders	Biological: TA-CD Drug: placebo	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Cocaine Vaccine for Methadone Maintained Patients

Resource links provided by NLM:

Drug Information available for: Cocaine hydrochloride

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Number of methadone maintained individuals who achieve 3 consecutive weeks of cocaine abstinence between Weeks 8 and 20

Estimated Enrollment:	125
Study Start Date:	July 2003
Study Completion Date:	June 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 TACD	Biological: TA-CD
Placebo Comparator: 2	Drug: placebo

Detailed Description:

Cocaine is a highly addictive stimulant that has high abuse potential. An effective drug to treat cocaine dependent individuals has yet to be found. Cocaine produces euphoric effects by blocking the re-uptake of neurotransmitters, such as dopamine, within the brain. The vaccine candidate TA-CD is a cocaine derivative coupled to recombinant cholera toxin B. It is designed to generate drug-specific antibodies that bind to cocaine and prevent it from travelling to the brain from the blood, thereby neutralizing its psychoaffective effect. The purpose of this study is to evaluate the effectiveness of TA-CD versus placebo in treating cocaine dependent individuals.

Eligibility

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

Criteria

Inclusion Criteria:

Moderate to severe cocaine or opioid dependence
Willing to enroll in methadone maintenance treatment
Demonstrates motivation to stop using cocaine
In good general health
If female, willing to use an adequate form of contraception for the duration of the study

Exclusion Criteria:

Currently suicidal or experiencing psychosis
History of psychosis or schizophrenia
Inability to read or understand English
Current dependence on drugs or alcohol other than cocaine, opiates, or tobacco
History of uveitis or ocular abnormalities associated with uveitis
Any concomitant disease or abnormalities that, in the opinion of the investigator, may interfere with the study
Requires psychotropic medications or steroids within 30 days of study entry
Immune deficiency
Ongoing active infection
HIV infected
Pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00142857

Locations

United States, Connecticut
VA Connecticut Health Care System
New Haven, Connecticut, United States, 06519

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Thomas R. Kosten, MD

Yale University, Department of Psychiatry

More Information

No publications provided by National Institute on Drug Abuse (NIDA)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00142857 History of Changes
Other Study ID Numbers:	NIDA-15477-1, R01-15477-1, DPMC
Study First Received:	September 1, 2005
Last Updated:	February 19, 2008
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):

Cocaine Dependence

Additional relevant MeSH terms:

Cocaine-Related Disorders
Substance-Related Disorders
Mental Disorders
Cocaine
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 02, 2012