Study of Bupe Maintenance Treatment for Opioid Dependence in Primary Care: NYC

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Study of Buprenorphine Maintenance Treatment for Opioid Dependence in Primary Care

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.
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http://www.clinicaltrials.gov/ct/show/NCT00471042?order=10

Inclusion Criteria:
18 Years-65 Years, Genders Eligible for Study: Both
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 start: June 2006; Expected completion: June 2008

Contact
Please refer to this study by ClinicalTrials.gov identifier NCT00471042

Alexandra Nelson, B.A. 212-543-6743

United States, New York
Columbia University/New York State Psychiatric Institute, New York, New York, 10032, United States; Recruiting
Erik W. Gunderson, M.D., Principal Investigator

Study chairs or principal investigators

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

(Please do not PM me in regards to this, I am not affiliated with this research)
 
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