Substance Abuse Pre-Treatment Screening Study

Study Overview
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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.

Official Title
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General Evaluation of Eligibility for Substance Abuse/Dependence Research

Conditions
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Cocaine Abuse, Cocaine Dependence, Opiate Dependence, Alcohol Dependence, Substance Abuse

Intervention / Treatment
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* Drug: modafinil
* Drug: d-amphetamine
* Drug: L-Dopa
* Drug: Naltrexone


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>Cocaine Dependent Subjects | Drug: modafinil<br>* 400 mg daily<br>* Other names: Provigil;Drug: d-amphetamine<br>* 60mg daily<br>* Other names: Dexedrine;Drug: L-Dopa<br>* 800/200mg daily<br>* Other names: Sinemet;Drug: Naltrexone<br>* 50mg daily<br>* Other names: Revia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine Toxicology |  | 6 weeks to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographics |  | 6 weeks to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Substance Abuse, Treatment, Eligibility