Project BEST: Buprenorphine Entry Into Substance Abuse Treatment

Study Overview
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Brief Summary
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Project BEST is a clinical project funded by the Substance Abuse and Mental Health Services Administration (SAMHSA) to increase treatment to opiate dependent patients with mental illness in New Haven, CT and to prospectively follow everyone enrolled in buprenorphine care for as long as the individual takes buprenorphine to track the success of buprenorphine for the maintenance of opiate dependence.

Detailed Description
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The investigators propose to create a prospective cohort that will track outcomes for an opiate dependent population on buprenorphine maintenance. Individuals who have already decided to undergo buprenorphine treatment in Project BEST will be invited to participate in the following data collection process. The investigators propose the following series of data collection to assess clients during their time in the cohort: GPRA, supplemental instrument, ASI, SCID, COWS, Urine toxicology. Patients who are enrolled will enter a standardized, manual based weekly counseling regimen. Urine toxicology will be performed a minimum of twice monthly, but will not occur at the same times monthly to decrease the probability of sampling error. This is a prospective cohort to follow a group of individuals on buprenorphine treatment. The goal of this prospective cohort is to generate thoughtful observations. Specific items of interest which will be compared with age, race matched historical controls on methadone will be: Changes in addiction severity over treatment time Changes in sexual risk behaviors and injection practices Improvements in urine toxicology Co-occurring mental illness

Official Title
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Project BEST: Buprenorphine Entry Into Substance Abuse Treatment

Conditions
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Opioid-related Disorders, HIV Infections, Hepatitis C, Chronic, Depression

Intervention / Treatment
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* Behavioral: MET/CBT based individualized counseling
* Drug: Buprenorphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Opiate dependent by DSM IV criteria - to be determined by clinician - on buprenorphine through the Project BEST Program. Exclusion Criteria: Inability to adhere to study instruments.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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

| Intervention/Treatment |
| --- |
|Behavioral: MET/CBT based individualized counseling|Manualized counseling with the first four week being MET followed by 8 weeks of CBT|
|Drug: Buprenorphine|Target dose in stabilization is 16 mg of buprenorphine to be taken sublingually once daily.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioid dependence, HIV/AIDS, Hepatitis C, Severe mental illness, Injection Drug Use