Substance Abuse Pre-Treatment Screening Study

Alcohol Dependence Clinical Trial

Official title:

General Evaluation of Eligibility for Substance Abuse/Dependence Research

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00439049
• Other study ID #: NIDA-09262-13
• Secondary ID: P50DA009262DPMCD
• Status: Recruiting
• Start date: October 2005
• Est. completion date: June 2026

Study information

• Verified date: December 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Jessica Vincent, BS
• Phone: 713-486-2803
• Email: Jessica.N.Vincent[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7500
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism
• Cocaine Abuse
• Cocaine Dependence
• Cocaine-Related Disorders
• Opiate Dependence
• Opioid-Related Disorders
• Substance Abuse
• Substance-Related Disorders

Intervention

Drug:
• modafinil
400 mg daily
• d-amphetamine
60mg daily
• L-Dopa
800/200mg daily
• Naltrexone
50mg daily

Locations

Country	Name	City	State
United States	University of Texas Medical School- Houston, Dept. of Psychiatry Mental Sciences Institute	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine Toxicology		6 weeks to 24 weeks
Secondary	Demographics		6 weeks to 24 weeks