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

Cocaine-Related Disorders Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00218049
• Other study ID #: NIDA-09262-10
• Secondary ID: P50-09262-10DPMC
• Status: Terminated
• Phase: Phase 1
• First received: September 16, 2005
• Last updated: January 11, 2017
• Start date: December 2004
• Est. completion date: July 2005

Study information

• Verified date: August 2008
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: July 2005
• Est. primary completion date: July 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine Abuse
• Cocaine-Related Disorders

Intervention

Drug:
• GBR 12909
50mg GBR 12909 over 12 days
• GBR 12909
GBR 12909 75 mg over 12 day period
• GBR 12909
GBR 12909 100 mg over 12 day period

Locations

Country	Name	City	State
United States	University of Texas Health Science Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)	University of Texas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication effects, including frequency of adverse events		12 days of trial	No