Substance Abuse Pre-Treatment Screening Study

Recruiting

• Conditions: Cocaine Abuse; Alcohol Dependence; Cocaine Dependence; Substance Abuse; Opiate Dependence
• Interventions: Drug: modafinil; Drug: d-amphetamine; Drug: L-Dopa; Drug: Naltrexone

• Registration Number: NCT00439049
• Lead Sponsor: The University of Texas Health Science Center, Houston

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 Timeline

• Study Start: 2005-10
• Study First Submitted: 2007-02-21
• Study First Submitted QC: 2007-02-21
• Study First Posted: 2007-02-22
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-19
• Last Update Posted: 2023-12-20
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 7500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	L-Dopa	Cocaine Dependent Subjects
A	modafinil	Cocaine Dependent Subjects
A	Naltrexone	Cocaine Dependent Subjects
A	d-amphetamine	Cocaine Dependent Subjects

Primary Outcome Measures

Name	Time	Method
Urine Toxicology	6 weeks to 24 weeks

Secondary Outcome Measures

Name	Time	Method
Demographics	6 weeks to 24 weeks

Trial Locations

Locations (1)

University of Texas Medical School- Houston, Dept. of Psychiatry Mental Sciences Institute; 🇺🇸 Houston, Texas, United States