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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00439049
Other study ID # NIDA-09262-13
Secondary ID P50DA009262DPMCD
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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