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
  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

Resource links provided by NLM:


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
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
University of Texas
Investigators
Principal Investigator: John Grabowski, PhD University of Texas
  More Information

No publications provided

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
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Vanoxerine
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014