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

Primary Purpose

Cocaine Abuse, Cocaine-Related Disorders

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GBR 12909
GBR 12909
GBR 12909
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Abuse

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Texas Health Science Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

1

2

3

Arm Description

50 mg of GBR 12909

75 mg of GBR 12909

100 mg of GBR 12909

Outcomes

Primary Outcome Measures

Medication effects, including frequency of adverse events

Secondary Outcome Measures

Full Information

First Posted
September 16, 2005
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
University of Texas
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1. Study Identification

Unique Protocol Identification Number
NCT00218049
Brief Title
Interaction Between Vanoxerine (GBR 12909) and Cocaine in Cocaine Dependent Individuals
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 Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Terminated
Why Stopped
Issue of priority of resources
Study Start Date
December 2004 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
University of Texas

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Abuse, Cocaine-Related Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
50 mg of GBR 12909
Arm Title
2
Arm Type
Experimental
Arm Description
75 mg of GBR 12909
Arm Title
3
Arm Type
Experimental
Arm Description
100 mg of GBR 12909
Intervention Type
Drug
Intervention Name(s)
GBR 12909
Intervention Description
50mg GBR 12909 over 12 days
Intervention Type
Drug
Intervention Name(s)
GBR 12909
Intervention Description
GBR 12909 75 mg over 12 day period
Intervention Type
Drug
Intervention Name(s)
GBR 12909
Intervention Description
GBR 12909 100 mg over 12 day period
Primary Outcome Measure Information:
Title
Medication effects, including frequency of adverse events
Time Frame
12 days of trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Grabowski, PhD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Science Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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

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