NCT00218075

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 examine the effectiveness of levodopa and carbidopa in treating cocaine dependent individuals. In addition, this study will examine the effects of incentive rewards for treatment compliance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2000

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2000

Completed
5.5 years 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
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

January 5, 2016

Status Verified

January 1, 2016

Enrollment Period

7.6 years

First QC Date

September 16, 2005

Last Update Submit

January 4, 2016

Conditions

Cocaine AbuseCocaine-Related Disorders

Keywords

Cocaine addictioncocaine treatment

Outcome Measures

Primary Outcomes (1)

  • Cocaine use

Secondary Outcomes (3)

  • Medication compliance

  • treatment retention

  • severity of addiction-related problems

Interventions

LevodopaDRUG
CarbidopaDRUG
Clinical ManagementBEHAVIORAL
Relapse Prevention TherapyBEHAVIORAL
Contingency ManagementBEHAVIORAL

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Meets DSM-IV criteria for current cocaine dependence
  • Provides at least one positive urine test for cocaine during study screening
  • Good general health, based on a physical exam, lab tests, and an electrocardiogram
  • Reads and writes English at a sixth grade level

You may not qualify if:

  • Current Axis I depressive, psychotic, or anxiety disorder
  • Currently in jail
  • Pregnant or breastfeeding
  • Requires certain medications

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

LevodopaCarbidopaSecondary Prevention

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DihydroxyphenylalanineCatecholaminesAminesOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsTyrosineMethyldopaHydrazinesTherapeuticsPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPublic Health PracticePublic HealthEnvironment and Public Health

Study Officials

  • John Grabowski, PhD

    University of Texas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor - Psy, Behavioral Science

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 22, 2005

Study Start

March 1, 2000

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

January 5, 2016

Record last verified: 2016-01

Locations

US(1)