Study of Buprenorphine Maintenance Treatment for Opioid Dependence in Primary Care

Opioid-Related Disorders Clinical Trial

Official title:

Buprenorphine for Treatment of Opioid Dependence in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00471042
• Other study ID #: #5258
• Secondary ID: NIDA-020000K23DA
• Status: Completed
• Start date: June 2006
• Est. completion date: August 2012

Study information

• Verified date: April 2019
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2012
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	Columbia University/New York State Psychiatric Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States,