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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)

Tracking Information
First Submitted Date  ICMJE September 16, 2005
First Posted Date  ICMJE September 22, 2005
Last Update Posted Date January 12, 2017
Study Start Date  ICMJE December 2004
Actual Primary Completion Date July 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2008)
Medication effects, including frequency of adverse events [ Time Frame: 12 days of trial ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 16, 2005)
Medication effects, including frequency of adverse events
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2005)
Behavioral/physiological effects of drugs alone and in combination
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Interaction Between Vanoxerine (GBR 12909) and Cocaine in Cocaine Dependent Individuals
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Cocaine Abuse
  • Cocaine-Related Disorders
Intervention  ICMJE
  • Drug: GBR 12909
    50mg GBR 12909 over 12 days
  • Drug: GBR 12909
    GBR 12909 75 mg over 12 day period
  • Drug: GBR 12909
    GBR 12909 100 mg over 12 day period
Study Arms  ICMJE
  • Experimental: 1
    50 mg of GBR 12909
    Intervention: Drug: GBR 12909
  • Experimental: 2
    75 mg of GBR 12909
    Intervention: Drug: GBR 12909
  • Experimental: 3
    100 mg of GBR 12909
    Intervention: Drug: GBR 12909
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 18, 2008)
3
Original Enrollment  ICMJE
 (submitted: September 16, 2005)
0
Actual Study Completion Date  ICMJE July 2005
Actual Primary Completion Date July 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00218049
Other Study ID Numbers  ICMJE NIDA-09262-10
P50-09262-10
DPMC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party F. Gerard Moeller, M.D., University of Texas Medical School at Houston
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE National Institute on Drug Abuse (NIDA)
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE University of Texas
Investigators  ICMJE
Principal Investigator: John Grabowski, PhD University of Texas
PRS Account National Institute on Drug Abuse (NIDA)
Verification Date August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP