Interaction Between Vanoxerine (GBR 12909) and Cocaine in Cocaine Dependent Individuals - Full Text View

Sponsors and Collaborators:	National Institute on Drug Abuse (NIDA) University of Texas
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00218049

Purpose

Cocaine dependence is a major public health problem; an effective primary treatment for cocaine dependent individuals has yet to be found. The purpose of this study is to determine the safety and effects of vanoxerine (GBR 12909) in treating cocaine dependent individuals.

Condition	Intervention	Phase
Cocaine Abuse Cocaine-Related Disorders	Drug: GBR 12909	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study
Official Title:	Phase 1, Double-Blind, Placebo-Controlled Assessment of Interactions Between 2 Doses of Cocaine and Three Doses of Escalating Vanoxerine (GBR 12909) in Cocaine Using Volunteers

Resource links provided by NLM:

Drug Information available for: Cocaine hydrochloride Vanoxerine Gbr 12909

U.S. FDA Resources

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

Primary Outcome Measures:

Medication effects, including frequency of adverse events [ Time Frame: 12 days of trial ] [ Designated as safety issue: No ]

Enrollment:	3
Study Start Date:	December 2004
Study Completion Date:	July 2005
Primary Completion Date:	July 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 50 mg of GBR 12909	Drug: GBR 12909 50mg GBR 12909 over 12 days
2: Experimental 75 mg of GBR 12909	Drug: GBR 12909 GBR 12909 75 mg over 12 day period
3: Experimental 100 mg of GBR 12909	Drug: GBR 12909 GBR 12909 100 mg over 12 day period

Detailed Description:

Cocaine is a strong central nervous system stimulant that is widely abused throughout the United Sates. Due to its widespread use, it is important to develop an effective treatment for cocaine dependence. Dopamine transporters (DAT) play an important role in the addictive nature of cocaine; the use of compounds that target DAT may be effective in treating cocaine dependent individuals. Research shows that GBR 12909 has a strong affinity for DAT. The purpose of this study is to determine the safety and potential interaction of GBR 12909 and cocaine in cocaine dependent individuals.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Meets DSM-IV criteria for current cocaine dependence
Not currently seeking treatment for cocaine dependence
Currently uses cocaine, as determined by a self-report and a positive urine test for cocaine, within 30 days prior to study entry
Within 20 % of ideal body weight, and weighs at least 100 lbs
Good general health
Normal electrocardiogram
Willing to use acceptable methods of contraception for the duration of the study

Exclusion Criteria:

Current or history of a major psychiatric illness, other than drug dependence or disorders secondary to drug abuse
Meets DSM-IV criteria for dependence on any drugs other than cocaine, marijuana, nicotine, or alcohol
Physiologically dependent on alcohol and requires medical detoxification
Use of prescription drugs within 14 days prior to study entry
Use of non-prescription drugs within 7 days prior to study entry
If female, used an oral contraceptive, Depo-Provera, Norplant, or intrauterine progesterone contraceptive system, within 30 days prior to study entry
Pregnant or breastfeeding
History of liver disease
Current elevated aspartate aminotransferase or alanine aminotransferase levels
Donated a unit of blood within 4 weeks prior to study entry
Participated in any other clinical investigation within 4 weeks prior to study entry
History of any illness or behavior that, in the opinion of the investigator, might interfere with the study
Family history of early significant cardiovascular disease
Exhibits Hepatitis B surface antigen or Hepatitis C antibody
HIV infected
Syphilis
Active tuberculosis
Adult asthma
Chronic obstructive pulmonary disease
Unable to distinguish between 20 mg and 40 mg of intravenous cocaine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00218049

Locations

United States, Texas
University of Texas Health Science Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

University of Texas

Investigators

Principal Investigator:

John Grabowski, PhD

University of Texas

More Information

No publications provided

Responsible Party:	University of Texas Medical School at Houston ( F. Gerard Moeller, M.D. )
Study ID Numbers:	NIDA-09262-10, P50-09262-10, DPMC
Study First Received:	September 16, 2005
Last Updated:	August 18, 2008
ClinicalTrials.gov Identifier:	NCT00218049 History of Changes
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Cocaine-Related Disorders
Dopamine Uptake Inhibitors
Vanoxerine
Neurotransmitter Agents
Central Nervous System Depressants
Disorders of Environmental Origin
Anesthetics
Cardiovascular Agents

Anesthetics, Local
Dopamine
Mental Disorders
Substance-Related Disorders
Vasoconstrictor Agents
Dopamine Agents
Peripheral Nervous System Agents
Cocaine

Additional relevant MeSH terms:

Cocaine-Related Disorders
Dopamine Uptake Inhibitors
Vanoxerine
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Disorders of Environmental Origin
Cardiovascular Agents

Anesthetics, Local
Pharmacologic Actions
Sensory System Agents
Mental Disorders
Therapeutic Uses
Substance-Related Disorders
Vasoconstrictor Agents
Dopamine Agents
Peripheral Nervous System Agents
Cocaine
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 01, 2009