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Clinical Trials/NCT00439049
NCT00439049
Recruiting
Not Applicable

General Evaluation of Eligibility for Substance Abuse/Dependence Research

The University of Texas Health Science Center, Houston1 site in 1 country7,500 target enrollmentOctober 2005

Overview

Phase
Not Applicable
Intervention
modafinil
Conditions
Cocaine Abuse
Sponsor
The University of Texas Health Science Center, Houston
Enrollment
7500
Locations
1
Primary Endpoint
Urine Toxicology
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The overarching goal of this project is to have a consolidated consent and evaluation procedure that will lead potential subjects to the most appropriate clinical trial or human laboratory study (and its consent process) for their presenting concerns or interests. A second purpose is to have a consolidated intake data base on which secondary analyses can be conducted.

Detailed Description

Approximately 1500 candidates per year will respond to advertisements and will complete preliminary telephone screening without identifiers. Appropriate candidates will be given appointment times and on arrival will undergo the consent process for evaluation. A complete medical, social, psychiatric, and drug use history will be obtained. Subjects fulfilling general health inclusion requirements will then be offered an appropriate study for which the specific consent will be obtained. The evaluation period will be no more than one day with all results evaluated within the two following days. Acceptable candidates will then be invited to complete the study specific consent.

Registry
clinicaltrials.gov
Start Date
October 2005
End Date
June 2026
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joy Schmitz

Professor - Psy, Behavioral Science

The University of Texas Health Science Center, Houston

Eligibility Criteria

Inclusion Criteria

  • Willing and able to participate in 3- to 6-month treatment program.
  • At least 18 years of age.
  • Seeking treatment for substances of abuse including (cocaine, opiates, and alcohol).
  • Generally physically healthy.

Exclusion Criteria

  • Pregnant or breastfeeding.
  • Mandated by the courts/parole officers to attend treatment.
  • Not seeking treatment for substances of abuse.
  • Plans to move from the Houston area within the 3- to 6-month treatment period.
  • Seeking treatment for a substance for which the Treatment Research Clinic (TRC) has no current trial.

Arms & Interventions

A

Cocaine Dependent Subjects

Intervention: modafinil

A

Cocaine Dependent Subjects

Intervention: d-amphetamine

A

Cocaine Dependent Subjects

Intervention: L-Dopa

A

Cocaine Dependent Subjects

Intervention: Naltrexone

Outcomes

Primary Outcomes

Urine Toxicology

Time Frame: 6 weeks to 24 weeks

Secondary Outcomes

  • Demographics(6 weeks to 24 weeks)

Study Sites (1)

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