Interaction Between Vanoxerine (GBR 12909) and Cocaine in Cocaine Dependent Individuals

This study has been terminated.

(Issue of priority of resources)

Sponsor:

Collaborator:

University of Texas

Information provided by:

National Institute on Drug Abuse (NIDA)

ClinicalTrials.gov Identifier:

NCT00218049

First received: September 16, 2005

Last updated: August 18, 2008

Last verified: August 2008

History of Changes

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 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

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
Experimental: 1 50 mg of GBR 12909	Drug: GBR 12909 50mg GBR 12909 over 12 days
Experimental: 2 75 mg of GBR 12909	Drug: GBR 12909 GBR 12909 75 mg over 12 day period
Experimental: 3 100 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 (Adult)
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

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: 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


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

Additional relevant MeSH terms:


Cocaine-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Cocaine Vanoxerine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs	Sensory System Agents Peripheral Nervous System Agents Vasoconstrictor Agents Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents

ClinicalTrials.gov processed this record on September 30, 2016

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