NCT00218049

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2004

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

January 12, 2017

Status Verified

August 1, 2008

Enrollment Period

7 months

First QC Date

September 16, 2005

Last Update Submit

January 11, 2017

Conditions

Cocaine AbuseCocaine-Related Disorders

Outcome Measures

Primary Outcomes (1)

  • Medication effects, including frequency of adverse events

    12 days of trial

Study Arms (3)

1

EXPERIMENTAL

50 mg of GBR 12909

Drug: GBR 12909

2

EXPERIMENTAL

75 mg of GBR 12909

Drug: GBR 12909

3

EXPERIMENTAL

100 mg of GBR 12909

Drug: GBR 12909

Interventions

GBR 12909DRUG

50mg GBR 12909 over 12 days

1

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Science Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

vanoxerine

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • John Grabowski, PhD

    University of Texas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 22, 2005

Study Start

December 1, 2004

Primary Completion

July 1, 2005

Study Completion

July 1, 2005

Last Updated

January 12, 2017

Record last verified: 2008-08

Locations

US(1)