Project BEST: Buprenorphine Entry Into Substance Abuse Treatment

NCT ID: NCT02583243

Last Updated: 2020-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

209 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-05-31

Study Completion Date

2008-08-31

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:

1. Changes in addiction severity over treatment time
2. Changes in sexual risk behaviors and injection practices
3. Improvements in urine toxicology
4. Co-occurring mental illness

Conditions

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Opioid-related Disorders HIV Infections Hepatitis C, Chronic Depression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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MET/CBT based individualized counseling

Manualized counseling with the first four week being MET followed by 8 weeks of CBT

Intervention Type BEHAVIORAL

Buprenorphine

Target dose in stabilization is 16 mg of buprenorphine to be taken sublingually once daily.

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frederick L Altice, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University AIDS Program

Locations

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Yale University

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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SAMHSA TCE/HIV 15767

Identifier Type: -

Identifier Source: secondary_id

0504027630_B

Identifier Type: -

Identifier Source: org_study_id

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