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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.
ClinicalTrials.gov Identifier: NCT00439049
Recruitment Status : Recruiting
First Posted : February 22, 2007
Last Update Posted : April 5, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

February 21, 2007
February 22, 2007
April 5, 2017
October 2005
June 2021   (Final data collection date for primary outcome measure)
Urine Toxicology [ Time Frame: 6 weeks to 24 weeks ]
Not Provided
Complete list of historical versions of study NCT00439049 on ClinicalTrials.gov Archive Site
Demographics [ Time Frame: 6 weeks to 24 weeks ]
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
Observational Model: Other
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
June 2021
June 2021   (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 Treatment Research Clinic (TRC) has no current trial.
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact: Jessica Vincent, BS 713-486-2803 Jessica.N.Vincent@uth.tmc.edu
United States
 
 
NCT00439049
NIDA-09262-13
P50DA009262 ( U.S. NIH Grant/Contract )
DPMCDA ( Other Identifier: NIDA )
Yes
Not Provided
Not Provided
Joy Schmitz, 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
April 2017