Study of Buprenorphine Maintenance Treatment for Opioid Dependence in Primary Care

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Columbia University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Columbia University
ClinicalTrials.gov Identifier:
NCT00471042
First received: May 7, 2007
Last updated: November 16, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Heroin Dependence
Opioid-Related Disorders
Substance Abuse, Intravenous
Drug: Buprenorphine

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Buprenorphine for Treatment of Opioid Dependence in Primary Care

Resource links provided by NLM:


Further study details as provided by Columbia University:

Estimated Enrollment: 60
Study Start Date: June 2006
Estimated Study Completion Date: August 2012
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Buprenorphine
    Dose is determined according to the participants' individual need.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00471042

Locations
United States, New York
Columbia University/New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Erik W. Gunderson, M.D. Columbia University
  More Information

No publications provided

Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT00471042     History of Changes
Other Study ID Numbers: 5258, NIDA-020000, K23-DA-020000
Study First Received: May 7, 2007
Last Updated: November 16, 2011
Health Authority: United States: Federal Government

Keywords provided by Columbia University:
Heroin Dependence
Opioid Dependence
Primary Care
Buprenorphine

Additional relevant MeSH terms:
Heroin Dependence
Opioid-Related Disorders
Substance Abuse, Intravenous
Substance-Related Disorders
Mental Disorders
Buprenorphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on July 29, 2014