Substance Abuse Pre-Treatment Screening Study

December 19, 2023 updated by: Joy Schmitz, The University of Texas Health Science Center, Houston

General Evaluation of Eligibility for Substance Abuse/Dependence Research

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

7500

Contacts and Locations

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

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77054
        • Recruiting
        • University of Texas Medical School- Houston, Dept. of Psychiatry Mental Sciences Institute
        • Contact:
        • Principal Investigator:
          • Joy M Schmitz, Ph.D.

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 60 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Cocaine Dependent Subjects

Description

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 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

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
Cocaine Dependent Subjects
Drug: modafinil
400 mg daily
Other Names:
  • Provigil
Drug: d-amphetamine
60mg daily
Other Names:
  • Dexedrine
Drug: L-Dopa
800/200mg daily
Other Names:
  • Sinemet
Drug: Naltrexone
50mg daily
Other Names:
  • Revia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Urine Toxicology
Time Frame: 6 weeks to 24 weeks
6 weeks to 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Demographics
Time Frame: 6 weeks to 24 weeks
6 weeks to 24 weeks

Collaborators and Investigators

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

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Joy M. Schmitz, PhD, The University of Texas Health Science Center, Houston
  • Principal Investigator: Frederick G Moeller, MD, The University of Texas Health Science Center, Houston
  • Principal Investigator: Angela L Stotts, PhD, The University of Texas Health Science Center, Houston

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

October 1, 2005

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

February 21, 2007

First Submitted That Met QC Criteria

February 21, 2007

First Posted (Estimated)

February 22, 2007

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-09262-13
  • DPMCDA (Other Identifier: NIDA)
  • P50DA009262 (U.S. NIH Grant/Contract)

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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