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

January 11, 2017 updated by: National Institute on Drug Abuse (NIDA)

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
50 mg of GBR 12909
Drug: GBR 12909
50mg GBR 12909 over 12 days
Drug: GBR 12909
GBR 12909 75 mg over 12 day period
Drug: GBR 12909
GBR 12909 100 mg over 12 day period
Experimental: 2
75 mg of GBR 12909
Drug: GBR 12909
50mg GBR 12909 over 12 days
Drug: GBR 12909
GBR 12909 75 mg over 12 day period
Drug: GBR 12909
GBR 12909 100 mg over 12 day period
Experimental: 3
100 mg of GBR 12909
Drug: GBR 12909
50mg GBR 12909 over 12 days
Drug: GBR 12909
GBR 12909 75 mg over 12 day period
Drug: GBR 12909
GBR 12909 100 mg over 12 day period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Medication effects, including frequency of adverse events
Time Frame: 12 days of trial
12 days of trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Drug Abuse (NIDA)

Collaborators

University of Texas

Investigators

  • Principal Investigator: John Grabowski, PhD, University of Texas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

July 1, 2005

Study Completion (Actual)

July 1, 2005

Study Registration Dates

First Submitted

September 16, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

January 12, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

August 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-09262-10
  • DPMC (Other Identifier: NIDA)
  • P50-09262-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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