Substance Abuse Pre-Treatment Screening Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by The University of Texas Health Science Center, Houston.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
F. Gerald Moeller, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00439049
First received: February 21, 2007
Last updated: May 3, 2013
Last verified: December 2009
  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: 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 The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Urine Toxicology [ Time Frame: 6 weeks to 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Demographics [ Time Frame: 6 weeks to 24 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

whole blood, serum, white cells


Estimated Enrollment: 7500
Study Start Date: October 2005
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: June 2013 (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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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 TRC has no current trial.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00439049

Contacts
Contact: Ann Garcia, MA 713-486-2804 Ann.D.Garcia@uth.tmc.edu

Locations
United States, Texas
University of Texas Medical School- Houston, Dept. of Psychiatry Mental Sciences Institute Recruiting
Houston, Texas, United States, 77030
Contact: Ann Garcia, MA    713-500-2804    Ann.D.Garcia@uth.tmc.edu   
Contact: Rhian W Farley, MBA    713-500-2639    Rhian.farley@uth.tmc.edu   
Principal Investigator: Joy M Schmitz, Ph.D.         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
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

No publications provided

Responsible Party: F. Gerald Moeller, 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, DPMCDA
Study First Received: February 21, 2007
Last Updated: May 3, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Alcoholism
Cocaine-Related Disorders
Opioid-Related Disorders
Substance-Related Disorders
Alcohol-Related Disorders
Mental Disorders
Amphetamine
Dextroamphetamine
Modafinil
Naltrexone
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors
Narcotic Antagonists
Sensory System Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on April 22, 2014