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 National Institute on Drug Abuse (NIDA). Recruitment status was Recruiting

First Received on February 21, 2007. Last Updated on December 7, 2009 History of Changes

Sponsor:	The University of Texas Health Science Center, Houston
Collaborator:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00439049

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:

MedlinePlus related topics: Alcoholism Methamphetamine

Drug Information available for: Methamphetamine hydrochloride Dextroamphetamine sulfate Dextroamphetamine Amphetamine sulfate Naltrexone Naltrexone hydrochloride Sinemet Modafinil Amphetamine Methamphetamine

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

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:	May 2010
Estimated Primary Completion Date:	May 2010 (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

713-500-2804

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: Frederick G Moeller, M.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

No publications provided

Responsible Party:	F. Gerard Moeller, M.D., UT 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:	December 7, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):

Substance Abuse
Treatment
Eligibility

Additional relevant MeSH terms:

Alcoholism
Cocaine-Related Disorders
Opioid-Related Disorders
Substance-Related Disorders
Alcohol-Related Disorders
Mental Disorders
Amphetamine
Methamphetamine
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 February 12, 2012