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Substance Abuse Pre-Treatment Screening Study

This study is currently recruiting participants.
Verified April 2017 by Joy Schmitz, The University of Texas Health Science Center, Houston
Sponsor:
ClinicalTrials.gov Identifier:
NCT00439049
First Posted: February 22, 2007
Last Update Posted: April 5, 2017
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.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Joy Schmitz, The University of Texas Health Science Center, Houston
  Purpose
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 Intervention
Cocaine Abuse Cocaine Dependence Opiate Dependence Alcohol Dependence Substance Abuse Drug: modafinil Drug: d-amphetamine Drug: L-Dopa Drug: Naltrexone

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: General Evaluation of Eligibility for Substance Abuse/Dependence Research

Resource links provided by NLM:


Further study details as provided by Joy Schmitz, The University of Texas Health Science Center, Houston:

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

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

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

Estimated Enrollment: 7500
Study Start Date: October 2005
Estimated Study Completion Date: June 2021
Estimated Primary Completion Date: June 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A
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

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.
  Eligibility

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.


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
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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00439049


Contacts
Contact: Jessica Vincent, BS 713-486-2803 Jessica.N.Vincent@uth.tmc.edu

Locations
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    Rolanda.Johnson@uth.tmc.edu   
Principal Investigator: Joy M Schmitz, Ph.D.         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
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
  More Information

Responsible Party: Joy Schmitz, Professor - Psy, Behavioral Science, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00439049     History of Changes
Other Study ID Numbers: NIDA-09262-13
P50DA009262 ( U.S. NIH Grant/Contract )
DPMCDA ( Other Identifier: NIDA )
First Submitted: February 21, 2007
First Posted: February 22, 2007
Last Update Posted: April 5, 2017
Last Verified: April 2017

Keywords provided by Joy Schmitz, The University of Texas Health Science Center, Houston:
Substance Abuse
Treatment
Eligibility

Additional relevant MeSH terms:
Alcoholism
Substance-Related Disorders
Cocaine-Related Disorders
Opioid-Related Disorders
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Amphetamine
Modafinil
Dextroamphetamine
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Sympathomimetics
Autonomic Agents
Dopamine Agents
Neurotransmitter Agents
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors