Buprenorphine Maintenance Treatment of Opioid Dependence in Primary Care: A Randomized Clinical Trial

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Analgesics, Opioid; Buprenorphine

Criteria

Inclusion Criteria:

1. DSM-IV criteria for current opioid dependence with physical dependence and are seeking treatment

2. Recent opioid use

3. Individuals must describe opioids as their primary drug of abuse.

4. 18-65 years of age

5. Able to give informed consent and comply with study procedures

6. Financially able to receive treatment at AIM and obtain medication (e.g., Medicaid)

Exclusion Criteria:

1. DSM-IV opioid dependence without physical dependence

2. 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).

3. Individuals who are significant risk for suicide based on their current mental state or history.

4. DSM-IV alcohol or benzodiazepine dependence with physiologic dependence.

5. Pregnancy, lactation. Women must also agree to use a method of contraception with proven efficacy and agree not to become pregnant during the study.

6. Unstable physical disorder that might make participation hazardous.

7. Individuals with a known allergy, sensitivity or adverse reaction to buprenorphine.

8. Past life-threatening idiosyncratic severe opioid withdrawal reaction (e.g., psychosis, seizure)

9. Current buprenorphine maintenance

10. Current long-acting opioid use (e.g., methadone)

11. Inability to read or understand the self-report assessment forms unaided