Clinical trial NCT00439049: Substance Abuse Pre-Treatment Screening Study
Official title: General Evaluation of Eligibility for Substance Abuse/Dependence Research
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cocaine Abuse
Cocaine Dependence
Opiate Dependence
Alcohol Dependence
Substance Abuse
Keywords: Substance Abuse
Treatment
Eligibility
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2007-02-22
Enrollment: 7500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cocaine Dependent Subjects

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.

Eligibility 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 Treatment Research Clinic (TRC) has no current trial.

Primary outcomes:
measure: Urine Toxicology
timeFrame: 6 weeks to 24 weeks
Secondary outcomes:
measure: Demographics
timeFrame: 6 weeks to 24 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Medical School- Houston, Dept. of Psychiatry Mental Sciences Institute
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Joy M. Schmitz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center, Houston
name: Frederick G Moeller, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center, Houston
name: Angela L Stotts, PhD
role: PRINCIPAL_INVESTIGATOR
References: