Recruiting

Observational Study

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT00439049

Conditions

Cocaine Abuse

Cocaine Dependence

Opiate Dependence

Alcohol Dependence

Substance Abuse

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

modafinil

d-amphetamine

L-Dopa

Naltrexone

Study Details

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.

Conditions

Cocaine Abuse

Cocaine Dependence

Opiate Dependence

Alcohol Dependence

Substance Abuse

Study ID

NCT00439049

Start date

Oct, 2005

Status verified date

Dec, 2023

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

7500 participants

Anticipated

Interventions and Outcome Measures

Arms

A

Cocaine Dependent Subjects

Interventions

modafinil

400 mg daily

d-amphetamine

60mg daily

L-Dopa

800/200mg daily

Naltrexone

50mg daily

Primary outcome measure

  • Urine Toxicology [ Time Frame: 6 weeks to 24 weeks ]

Central Contacts and Locations

Central contacts

Jessica Vincent, BS

713-486-2803Jessica.N.Vincent@uth.tmc.edu

Locations

University of Texas Medical School- Houston, Dept. of Psychiatry Mental Sciences Institute

Recruiting

Houston, Texas, United States, 77054

Contacts

Rolanda Johnson, MA

713-486-2823Rolanda.Johnson@uth.tmc.edu

Principal Investigator:

Joy M Schmitz, Ph.D.

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Dec 20, 2023

Last verified

Dec, 2023

Keywords

  • Substance Abuse
  • Treatment
  • Eligibility

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2023-12-20.