Project BEST: Buprenorphine Entry Into Substance Abuse Treatment

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.

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Key information

Conditions

Opioid-related Disorders Acquired Immunodeficiency Syndrome Behavior Behavioral Symptoms Blood-Borne Infections Chemically-Induced Disorders Chronic Disease Communicable Diseases Depression Digestive System Diseases Disease Attributes Flaviviridae Infections Genital Diseases HIV Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Diseases Mental Disorders Narcotic-Related Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Substance-Related Disorders Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale University

New Haven, Connecticut, 06510, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MET/CBT based individualized counseling

Behavioral

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

buprenorphine

Drug

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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start: 2005
Primary completion: 2008
Study completion: 2008
First posted: Oct 22, 2015
Registry last updated: Apr 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed