Study of Buprenorphine Maintenance Treatment for Opioid Dependence in Primary Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00471042
Recruitment Status : Completed
First Posted : May 9, 2007
Last Update Posted : May 20, 2015
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute

Brief Summary:
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 or disease Intervention/treatment
Heroin Dependence Opioid-Related Disorders Substance Abuse, Intravenous Drug: Buprenorphine

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
Actual Enrollment : 30 participants
Time Perspective: Prospective
Official Title: Buprenorphine for Treatment of Opioid Dependence in Primary Care
Study Start Date : June 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: Buprenorphine
    Dose is determined according to the participants' individual need.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults aged 18-65 who are seeking buprenorphine maintenance treatment for opioid dependence

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00471042

United States, New York
Columbia University/New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Principal Investigator: Erik W. Gunderson, M.D. Columbia University

Responsible Party: New York State Psychiatric Institute Identifier: NCT00471042     History of Changes
Other Study ID Numbers: #5258
K23DA020000 ( U.S. NIH Grant/Contract )
First Posted: May 9, 2007    Key Record Dates
Last Update Posted: May 20, 2015
Last Verified: May 2015

Keywords provided by New York State Psychiatric Institute:
Heroin Dependence
Opioid Dependence
Primary Care

Additional relevant MeSH terms:
Substance-Related Disorders
Opioid-Related Disorders
Heroin Dependence
Substance Abuse, Intravenous
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists