Substance Abuse Pre-Treatment Screening Study

Sponsor

The University of Texas Health Science Center, Houston (Other)

Overall Status

Recruiting

CT.gov ID

NCT00439049

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

7,500

Enrollment

Location

212

Duration (Months)

35.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cocaine Abuse Cocaine Dependence Opiate Dependence Alcohol Dependence Substance Abuse	Drug: modafinil Drug: d-amphetamine Drug: L-Dopa Drug: Naltrexone

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 Design

Study Type:

Observational

Anticipated Enrollment :

7500 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

General Evaluation of Eligibility for Substance Abuse/Dependence Research

Study Start Date :

Oct 1, 2005

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
A Cocaine Dependent Subjects	Drug: modafinil 400 mg daily Other Names: Provigil Drug: d-amphetamine 60mg daily Other Names: Dexedrine Drug: L-Dopa 800/200mg daily Other Names: Sinemet Drug: Naltrexone 50mg daily Other Names: Revia

Arm

Intervention/Treatment

Cocaine Dependent Subjects

Drug: modafinil

400 mg daily

Other Names:

Provigil

Drug: d-amphetamine

60mg daily

Other Names:

Dexedrine

Drug: L-Dopa

800/200mg daily

Other Names:

Sinemet

Drug: Naltrexone

50mg daily

Other Names:

Revia

Outcome Measures

Primary Outcome Measures

Urine Toxicology [6 weeks to 24 weeks]

Secondary Outcome Measures

Demographics [6 weeks to 24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas Medical School- Houston, Dept. of Psychiatry Mental Sciences Institute	Houston	Texas	United States	77054

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