Status:
TERMINATED
Interaction Between Vanoxerine (GBR 12909) and Cocaine in Cocaine Dependent Individuals
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Collaborating Sponsors:
University of Texas
Conditions:
Cocaine Abuse
Cocaine-Related Disorders
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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 effe...
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 depende...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2005
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00218049
Start Date
December 1 2004
End Date
July 1 2005
Last Update
January 12 2017
Active Locations (1)
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1
University of Texas Health Science Center
Houston, Texas, United States, 77030