Status:
COMPLETED
Buprenorphine Maintenance Treatment of Opioid Dependence in Primary Care: A Randomized Clinical Trial
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Opioid-Related Disorders
Heroin Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
The study will assess the effectiveness of at-home vs. in-office induction for patients entering buprenorphine maintenance at Associates in Internal Medicine (AIM) primary care clinic.
Detailed Description
Buprenorphine maintenance is an effective treatment for opioid dependence, yet diffusion has been limited. Physician concern about induction is a reported barrier, primarily as buprenorphine may preci...
Eligibility Criteria
Inclusion
- DSM-IV criteria for current opioid dependence with physical dependence and are seeking treatment
- Recent opioid use
- Individuals must describe opioids as their primary drug of abuse.
- 18-65 years of age
- Able to give informed consent and comply with study procedures
- Financially able to receive treatment at AIM and obtain medication (e.g., Medicaid)
Exclusion
- DSM-IV opioid dependence without physical dependence
- Any current Axis I psychiatric disorder(s) as defined by DSM-IV-TR that in the investigator's judgment are unstable or would be disrupted by study participation (e.g., psychosis, active suicidal or homicidal ideation).
- Individuals who are significant risk for suicide based on their current mental state or history.
- DSM-IV alcohol or benzodiazepine dependence with physiologic dependence.
- Pregnancy, lactation. Women must also agree to use a method of contraception with proven efficacy and agree not to become pregnant during the study.
- Unstable physical disorder that might make participation hazardous.
- Individuals with a known allergy, sensitivity or adverse reaction to buprenorphine.
- Past life-threatening idiosyncratic severe opioid withdrawal reaction (e.g., psychosis, seizure)
- Current buprenorphine maintenance
- Current long-acting opioid use (e.g., methadone)
- Inability to read or understand the self-report assessment forms unaided
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00684554
Start Date
December 1 2007
End Date
April 1 2010
Last Update
April 24 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Columbia University/New York State Psychiatric Institute
New York, New York, United States, 10032