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| Sponsor: | Columbia University |
|---|---|
| Collaborator: |
National Institute on Drug Abuse (NIDA) |
| Information provided by (Responsible Party): | Columbia University |
| ClinicalTrials.gov Identifier: | NCT00684554 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Opioid-Related Disorders Heroin Dependence |
Drug: Buprenorphine |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Buprenorphine Maintenance Treatment of Opioid Dependence in Primary Care: A Randomized Clinical Trial of At-Home Versus In-Office Buprenorphine Induction |
| Estimated Enrollment: | 20 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | April 2012 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
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 precipitate withdrawal due to its partial opioid agonist activity and high receptor binding affinity. To minimize risk, guidelines recommend in-office assessment and monitoring during induction. As this may not be feasible (e.g., time limitations), many patients are instructed to self-induct at home. While this may facilitate treatment entry, data on at-home induction are limited. 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. Currently, patients receive buprenorphine maintenance at AIM as part of standard clinical practice and through an observational study (IRB 5258). Most patients are insured through Medicaid, which covers visit, medication (obtained through prescription from a local pharmacy), lab, and outside psychosocial treatment cost. In this demonstration project, 20 opioid dependent patients will be randomly assigned to at-home or in-office induction, and then monitored for 12 weeks. Ancillary psychosocial treatment will be encouraged but not required. After randomization, AIM clinic and NYSPI research visits will be scheduled weekly for 4 weeks, and then at weeks 8 and 12. The primary outcome will include a comparison of the proportion of patients successfully inducted one week after the initial primary care visit. Secondary outcomes will include: 1) Time to stabilization after buprenorphine initiation assessed by: a) Time until the patient is without withdrawal for two consecutive days, and b) Time until the patient is opioid free for two consecutive weeks; and 3) Retention-in-treatment at 4 and 12 weeks. Other secondary outcomes include patient satisfaction and change in addiction severity. These data will provide important information in buprenorphine initiation in primary care and enable determination of treatment effects size prior to future clinical trials.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Adults aged 18-65 who are seeking buprenorphine maintenance treatment for opioid dependence
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Responsible Party: | Columbia University |
| ClinicalTrials.gov Identifier: | NCT00684554 History of Changes |
| Other Study ID Numbers: | 5600, NIDA-020000 K23-DA-020000 |
| Study First Received: | May 22, 2008 |
| Last Updated: | November 16, 2011 |
| Health Authority: | United States: Federal Government |
|
Heroin Dependence Opioid Dependence Primary Care Buprenorphine |
|
Heroin Dependence Opioid-Related Disorders Substance-Related Disorders Mental Disorders Buprenorphine Analgesics, Opioid Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotic Antagonists Narcotics |