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Substance Abuse Pre-Treatment Screening Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00439049
Recruitment Status : Recruiting
First Posted : February 22, 2007
Last Update Posted : November 4, 2020
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Joy Schmitz, The University of Texas Health Science Center, Houston

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.

Condition or disease Intervention/treatment
Cocaine Abuse Cocaine Dependence Opiate Dependence Alcohol Dependence Substance Abuse Drug: modafinil Drug: d-amphetamine Drug: L-Dopa Drug: Naltrexone

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.

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Study Type : Observational
Estimated Enrollment : 7500 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: General Evaluation of Eligibility for Substance Abuse/Dependence Research
Study Start Date : October 2005
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Cocaine Dependent Subjects
Drug: modafinil
400 mg daily
Other Name: Provigil

Drug: d-amphetamine
60mg daily
Other Name: Dexedrine

Drug: L-Dopa
800/200mg daily
Other Name: Sinemet

Drug: Naltrexone
50mg daily
Other Name: Revia

Primary Outcome Measures :
  1. Urine Toxicology [ Time Frame: 6 weeks to 24 weeks ]

Secondary Outcome Measures :
  1. Demographics [ Time Frame: 6 weeks to 24 weeks ]

Biospecimen Retention:   Samples With DNA
whole blood, serum, white cells

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cocaine Dependent Subjects

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00439049

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Contact: Jessica Vincent, BS 713-486-2803

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United States, Texas
University of Texas Medical School- Houston, Dept. of Psychiatry Mental Sciences Institute Recruiting
Houston, Texas, United States, 77054
Contact: Rolanda Johnson, MA    713-486-2823   
Principal Investigator: Joy M Schmitz, Ph.D.         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
National Institute on Drug Abuse (NIDA)
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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
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Responsible Party: Joy Schmitz, Professor - Psy, Behavioral Science, The University of Texas Health Science Center, Houston Identifier: NCT00439049    
Other Study ID Numbers: NIDA-09262-13
P50DA009262 ( U.S. NIH Grant/Contract )
DPMCDA ( Other Identifier: NIDA )
First Posted: February 22, 2007    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Keywords provided by Joy Schmitz, The University of Texas Health Science Center, Houston:
Substance Abuse
Additional relevant MeSH terms:
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Substance-Related Disorders
Cocaine-Related Disorders
Opioid-Related Disorders
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Stimulants
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Autonomic Agents
Dopamine Agents
Neurotransmitter Agents
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors