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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Cocaine Abuse; Cocaine-Related Disorders	Drug: GBR 12909	Phase 1

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.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	3 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, 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
Study Start Date :	December 2004
Actual Primary Completion Date :	July 2005
Actual Study Completion Date :	July 2005

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Medication effects, including frequency of adverse events [ Time Frame: 12 days of trial ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	September 22, 2005
Last Update Posted:	January 12, 2017
Last Verified:	August 2008

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