Substance Abuse Pre-Treatment Screening Study

NCT ID: NCT00439049

Last Updated: 2023-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

7500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-10-31

Study Completion Date

2026-06-30

Brief Summary

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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

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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.

Conditions

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Cocaine Abuse Cocaine Dependence Opiate Dependence Alcohol Dependence Substance Abuse

Keywords

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Substance Abuse Treatment Eligibility

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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A

Cocaine Dependent Subjects

modafinil

Intervention Type DRUG

400 mg daily

d-amphetamine

Intervention Type DRUG

60mg daily

L-Dopa

Intervention Type DRUG

800/200mg daily

Naltrexone

Intervention Type DRUG

50mg daily

Interventions

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modafinil

400 mg daily

Intervention Type DRUG

d-amphetamine

60mg daily

Intervention Type DRUG

L-Dopa

800/200mg daily

Intervention Type DRUG

Naltrexone

50mg daily

Intervention Type DRUG

Other Intervention Names

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Provigil Dexedrine Sinemet Revia

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Joy Schmitz

Professor - Psy, Behavioral Science

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joy M. Schmitz, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Frederick G Moeller, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Angela L Stotts, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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University of Texas Medical School- Houston, Dept. of Psychiatry Mental Sciences Institute

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jessica Vincent, BS

Role: CONTACT

Phone: 713-486-2803

Email: [email protected]

Facility Contacts

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Rolanda Johnson, MA

Role: primary

Other Identifiers

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P50DA009262

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DPMCDA

Identifier Type: OTHER

Identifier Source: secondary_id

NIDA-09262-13

Identifier Type: -

Identifier Source: org_study_id