Substance Abuse Pre-Treatment Screening Study

This study is currently recruiting participants.

Verified December 2009 by The University of Texas Health Science Center, Houston

Sponsor:

Collaborator:

National Institute on Drug Abuse (NIDA)

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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 21, 2007

Last Updated Date

May 3, 2013

Start Date ^ICMJE

October 2005

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00439049 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Demographics [ Time Frame: 6 weeks to 24 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Substance Abuse Pre-Treatment Screening Study

Official Title ^ICMJE

General Evaluation of Eligibility for Substance Abuse/Dependence Research

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.

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

whole blood, serum, white cells

Sampling Method

Non-Probability Sample

Study Population

Cocaine Dependent Subjects

Condition ^ICMJE

Cocaine Abuse
Cocaine Dependence
Opiate Dependence
Alcohol Dependence
Substance Abuse

Intervention ^ICMJE

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

Study Group/Cohort (s)

Cocaine Dependent Subjects

Interventions:

Drug: modafinil
Drug: d-amphetamine
Drug: L-Dopa
Drug: Naltrexone

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

7500

Estimated Completion Date

September 2013

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Ann Garcia, MA

713-486-2804

Ann.D.Garcia@uth.tmc.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00439049

Other Study ID Numbers ^ICMJE

NIDA-09262-13, P50DA009262, DPMCDA

Has Data Monitoring Committee

Yes

Responsible Party

F. Gerald Moeller, The University of Texas Health Science Center, Houston

Study Sponsor ^ICMJE

The University of Texas Health Science Center, Houston

Collaborators ^ICMJE

National Institute on Drug Abuse (NIDA)

Investigators ^ICMJE

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

Information Provided By

The University of Texas Health Science Center, Houston

Verification Date

December 2009

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

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