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Project BEST: Buprenorphine Entry Into Substance Abuse Treatment

Project BEST: Buprenorphine Entry Into Substance Abuse Treatment

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02583243
Enrollment
209
Registered
2015-10-22
Start date
2005-05-31
Completion date
2008-08-31
Last updated
2020-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Opioid dependence, HIV/AIDS, Hepatitis C, Severe mental illness, Injection Drug Use

Brief 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.

Detailed 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

Interventions

BEHAVIORALMET/CBT based individualized counseling

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

DRUGBuprenorphine

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

Sponsors

Yale University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026