Project BEST: Buprenorphine Entry Into Substance Abuse Treatment

Depression Clinical Trial

Official title:

Project BEST: Buprenorphine Entry Into Substance Abuse Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02583243
• Other study ID #: 0504027630_B
• Secondary ID: SAMHSA TCE/HIV 1
• Status: Completed
• Start date: May 2005
• Est. completion date: August 2008

Study information

• Verified date: April 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic
• HIV Infections
• Opioid-related Disorders
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States,