Study of Buprenorphine Maintenance Treatment for Opioid Dependence in Primary Care

NCT00471042 | Completed

• 3 other identifiers: #5258NIDA-020000K23DA020000
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Heroin Dependence; Opioid-Related Disorders; Substance Abuse, Intravenous

Keywords

Heroin Dependence; Opioid Dependence; Primary Care; Buprenorphine

Interventions

Buprenorphine DRUG

Dose is determined according to the participants' individual need.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Columbia University/New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Heroin Dependence; Opioid-Related Disorders; Substance Abuse, Intravenous

Interventions

Buprenorphine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Erik W. Gunderson, M.D.

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Substance Use Disorder

Study Record Dates

• First Submitted: May 7, 2007
• First Posted: May 9, 2007
• Study Start: June 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2012
• Last Updated: April 23, 2019

Record last verified: 2019-04

Locations

US (1)