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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

February 21, 2007
May 3, 2013
October 2005
June 2013   (final data collection date for primary outcome measure)
Urine Toxicology [ Time Frame: 6 weeks to 24 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00439049 on ClinicalTrials.gov Archive Site
Demographics [ Time Frame: 6 weeks to 24 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Substance Abuse Pre-Treatment Screening Study
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.

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.

Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

whole blood, serum, white cells

Non-Probability Sample

Cocaine Dependent Subjects

  • Cocaine Abuse
  • Cocaine Dependence
  • Opiate Dependence
  • Alcohol Dependence
  • Substance Abuse
  • 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
A
Cocaine Dependent Subjects
Interventions:
  • Drug: modafinil
  • Drug: d-amphetamine
  • Drug: L-Dopa
  • Drug: Naltrexone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
7500
September 2013
June 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
No
Contact: Ann Garcia, MA 713-486-2804 Ann.D.Garcia@uth.tmc.edu
United States
 
NCT00439049
NIDA-09262-13, P50DA009262, DPMCDA
Yes
F. Gerald Moeller, The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
National Institute on Drug Abuse (NIDA)
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
The University of Texas Health Science Center, Houston
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP