Study of Buprenorphine Maintenance Treatment for Opioid Dependence in Primary Care
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|ClinicalTrials.gov Identifier: NCT00471042|
Recruitment Status : Completed
First Posted : May 9, 2007
Last Update Posted : October 31, 2018
|Condition or disease||Intervention/treatment|
|Heroin Dependence Opioid-Related Disorders Substance Abuse, Intravenous||Drug: Buprenorphine|
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|
|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|
- Drug: Buprenorphine
Dose is determined according to the participants' individual need.
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 ClinicalTrials.gov identifier (NCT number): NCT00471042
|United States, New York|
|Columbia University/New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Principal Investigator:||Erik W. Gunderson, M.D.||Columbia University|