Study of Buprenorphine Maintenance Treatment for Opioid Dependence in Primary Care

April 22, 2019 updated by: Frances R Levin, New York State Psychiatric Institute

Buprenorphine for Treatment of Opioid Dependence in Primary Care

The purpose of this treatment research study is to assess the effectiveness of buprenorphine maintenance treatment for opioid dependence delivered in a primary care clinic setting. This study will determine whether buprenorphine treatment in primary care is effective in reducing cravings, reducing illicit opioid use, reducing addiction severity, and retaining patients in primary care treatment for opioid dependence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Buprenorphine maintenance treatment of opioid dependence in primary care may expand treatment access. Buprenorphine is a partial mu-opioid agonist approved for treatment of opioid dependence (dependence on heroin, prescription opioid pain medication, or methadone), which can be prescribed in primary care by authorized physicians. The purpose of this study is to assess the effectiveness of buprenorphine maintenance treatment in a primary care setting. Outcome measures include illicit opioid use during treatment, addiction severity scores from the Addiction Severity Index (ASI), patient craving ratings on a 100mm visual analog scale (VAS), and patient retention in treatment.

This is a 6-month, prospective cohort study of adults aged 18-65 who are seeking buprenorphine maintenance treatment for opioid dependence. This study is observational, not experimental, and patients will be treated in a naturalistic condition according to their individual treatment needs. Clinic visits will occur weekly for the first 4 weeks (Induction and Stabilization Phases), and monthly for the remaining 20 weeks (Maintenance Phase), at which time up to a month of medication may be prescribed. Participation in ancillary psychosocial treatment is recommended but not required. Urine toxicology and craving ratings will be collected at each visit. Additionally, research visits will occur monthly to collect data assessing addiction severity, risk factors, general health, and psychiatric symptoms.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University/New York State Psychiatric Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults aged 18-65 who are seeking buprenorphine maintenance treatment for opioid dependence

Description

Inclusion Criteria:

  • DSM-IV criteria for current opioid dependence
  • Must be seeking treatment
  • Must describe opioid medication or heroin as primary drug of abuse
  • Must be financially able to receive treatment at the primary care clinic site and to receive medication (e.g., Medicaid)
  • Able to give informed consent and comply with study procedures

Exclusion Criteria:

  • Axis I psychiatric disorder(s) as defined by DSM-IV-TR that are unstable or would be disrupted by study participation
  • Individuals at significant risk for suicide based on current mental state
  • DSM-IV dependence with physiologic dependence other than opioid and nicotine
  • Women must not be pregnant or lactating, and must agree to use a proven effective method of contraception and not become pregnant during the study
  • Unstable physical disorder that might make participation hazardous
  • Known allergy, sensitivity or adverse reaction to buprenorphine
  • Current buprenorphine maintenance
  • Inability to read or understand the self-report assessment forms unaided

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Erik W. Gunderson, M.D., Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

May 7, 2007

First Submitted That Met QC Criteria

May 7, 2007

First Posted (Estimate)

May 9, 2007

Study Record Updates

Last Update Posted (Actual)

April 23, 2019

Last Update Submitted That Met QC Criteria

April 22, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #5258
  • NIDA-020000
  • K23DA020000 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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