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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00218049
Recruitment Status : Terminated (Issue of priority of resources)
First Posted : September 22, 2005
Last Update Posted : January 12, 2017
Sponsor:
Collaborator:
University of Texas
Information provided by:
National Institute on Drug Abuse (NIDA)

Study Description
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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 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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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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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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00218049


Locations
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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
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Principal Investigator: John Grabowski, PhD University of Texas
More Information
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Responsible Party: F. Gerard Moeller, M.D., University of Texas Medical School at Houston
ClinicalTrials.gov Identifier: NCT00218049    
Other Study ID Numbers: NIDA-09262-10
P50-09262-10
DPMC
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: August 2008
Additional relevant MeSH terms:
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Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Vanoxerine
Dopamine Uptake Inhibitors
 Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs