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

NCT ID: NCT00218049

Last Updated: 2017-01-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2005-07-31

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.

Conditions

Cocaine Abuse; Cocaine-Related Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

50 mg of GBR 12909

Group Type: EXPERIMENTAL

GBR 12909

Intervention Type: DRUG

50mg GBR 12909 over 12 days

2

75 mg of GBR 12909

Group Type: EXPERIMENTAL

GBR 12909

Intervention Type: DRUG

GBR 12909 75 mg over 12 day period

3

100 mg of GBR 12909

Group Type: EXPERIMENTAL

GBR 12909

Intervention Type: DRUG

GBR 12909 100 mg over 12 day period

Interventions

GBR 12909

50mg GBR 12909 over 12 days

Intervention Type: DRUG

GBR 12909

GBR 12909 75 mg over 12 day period

Intervention Type: DRUG

GBR 12909

GBR 12909 100 mg over 12 day period

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Texas

OTHER

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: lead

Responsible Party

University of Texas Medical School at Houston

Principal Investigators

John Grabowski, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

University of Texas Health Science Center

Houston, Texas, United States

Countries

United States

Other Identifiers

P50-09262-10

Identifier Type: -

Identifier Source: secondary_id

DPMC

Identifier Type: -

Identifier Source: secondary_id

NIDA-09262-10

Identifier Type: -

Identifier Source: org_study_id