ClinicalTrials.gov

History of Changes for Study: NCT00218049
Vanoxerine (GBR 12909) in Treating Cocaine Dependent Individuals - 10
Latest version (submitted January 11, 2017) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 September 16, 2005 None (earliest Version on record)
2 November 3, 2005 Study Status
3 November 21, 2005 Study Status and Study Identification
4 March 30, 2006 Contacts/Locations, Eligibility, Study Description, Study Status, Outcome Measures, Arms and Interventions, Study Design, Oversight and Study Identification
5 July 9, 2007 Study Status
6 August 18, 2008 Recruitment Status, Study Status, Arms and Interventions, Study Design, Outcome Measures, Oversight and Sponsor/Collaborators
7 January 11, 2017 Study Identification and Study Status
Comparison Format:

Scroll up to access the controls

Study NCT00218049
Submitted Date:  September 16, 2005 (v1)

Open or close this module Study Identification
Unique Protocol ID: NIDA-09262-10
Brief Title: Vanoxerine (GBR 12909) in Treating Cocaine Dependent Individuals - 10
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
Secondary IDs: P50-09262-10
Open or close this module Study Status
Record Verification: September 2005
Overall Status: Completed
Study Start: December 2004
Primary Completion:
Study Completion: March 2005
First Submitted: September 16, 2005
First Submitted that
Met QC Criteria:
September 16, 2005
First Posted: September 22, 2005 [Estimate]
Last Update Submitted that
Met QC Criteria:
September 16, 2005
Last Update Posted: September 22, 2005 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: National Institute on Drug Abuse (NIDA)
Responsible Party:
Collaborators: University of Texas
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: The purpose of this study is to determine the safety and effects of vanoxerine (GBR 12909) as a potential pharmacotherapy for cocaine abuse and dependence. This includes direct effects, side effects, and adverse events of GBR 12909 alone and in combination with cocaine.
Detailed Description:

Given the obvious importance of DAT in the addictive properties of cocaine, the development of compounds that target DAT represents a logical approach for treatment of cocaine dependence. In vitro pre clinical studies have shown that vanoxerine (GBR 12909) has a strong affinity for the dopamine transporter. GBR 12909 produces dopamine-like agonist effects and therefore may be effective in treating cocaine dependent individuals.

This phase 1 study examines the potential interaction between GBR 12909 and cocaine in cocaine dependent individuals.

Open or close this module Conditions
Conditions: Cocaine Abuse
Cocaine-Related Disorders
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Parallel Assignment
Number of Arms:
Masking: Double (masked roles unspecified)
Allocation: Randomized
Enrollment: 0
Open or close this module Arms and Interventions
Intervention Details:
Drug: Valproate
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Medication effects, including frequency of adverse events
Secondary Outcome Measures:
1. Behavioral/physiological effects of drugs alone and in combination
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 45 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Within 20% of ideal body weight, and must weigh at least 100 lbs.
  • 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 postivie urine test for cocaine within 30 days prior to enrollment
  • If female, have a negative pregnancy test within 72 hours prior to receiving the first dose of the investigational medication and agrees to use an effective method of contraception for the duration of the study
  • In general good health, without clinically significant abnormalities, as determined by the study clinician
  • Normal electrocardiogram, demonstrating normal sinus rhythm and no clinically significant abnormalities

Exclusion Criteria:

  • Meets DSM-IV criteria for any 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 requiring medical detoxification
  • Use of prescription drugs within 14 days prior to enrollment or non-prescription drugs within 7 days prior to enrollment
  • If female, used an oral contraceptive, including Depo-Provera, Norplant or intrauterine progesterone contraceptive system, within 30 days prior to enrollment
  • Pregnant or breastfeeding
  • History of liver disease
  • Current elevation of aspartate aminotransferase or alanine aminotransferase exceeding the upper normal limit
  • Donated a unit of blood or participated in any other clinical investigation within 4 weeks of enrollment
  • History of any illness, or family history of early significant cardiovascular disease, or a history of a behavior that, in the opinion of the investigator, might interefere with study completion
  • Seropositive for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) types 1 and 2
  • Seropositive for syphilis by rapid plasma reagin test
  • Active tuberculosis with a positive purified protein derivative (PPD) skin test, confirmed by a chest x-ray
  • Adult asthma or chronic obstructive pulmonary disease (CPOD), including those with current or recent (within the 2 years prior to enrollment) treatment with any inhaled or oral beta-agonist
  • Unable to distinguish between 20 and 40 mg of intravenous cocaine
Open or close this module Contacts/Locations
Study Officials: John Grabowski, Ph.D.
Principal Investigator
University of Texas
Locations: United States, Texas
University of Texas Health Science Center
San Antonio, Texas, United States, 78284
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services