Substance Abuse Pre-Treatment Screening Study

Overview

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.

Full Title of Study: “General Evaluation of Eligibility for Substance Abuse/Dependence Research”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2021

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.

Interventions

  • Drug: modafinil
    • 400 mg daily
  • Drug: d-amphetamine
    • 60mg daily
  • Drug: L-Dopa
    • 800/200mg daily
  • Drug: Naltrexone
    • 50mg daily

Arms, Groups and Cohorts

  • A
    • Cocaine Dependent Subjects

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Demographics
    • Time Frame: 6 weeks to 24 weeks

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The University of Texas Health Science Center, Houston
  • Collaborator
    • National Institute on Drug Abuse (NIDA)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Joy Schmitz, Professor – Psy, Behavioral Science – The University of Texas Health Science Center, Houston
  • Overall Official(s)
    • Joy M. Schmitz, PhD, Principal Investigator, The University of Texas Health Science Center, Houston
    • Frederick G Moeller, MD, Principal Investigator, The University of Texas Health Science Center, Houston
    • Angela L Stotts, PhD, Principal Investigator, The University of Texas Health Science Center, Houston
  • Overall Contact(s)
    • Jessica Vincent, BS, 713-486-2803, Jessica.N.Vincent@uth.tmc.edu

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