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

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00684554
First received: May 22, 2008
Last updated: April 6, 2016
Last verified: April 2016
  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 Phase
Opioid-Related Disorders
Heroin Dependence
Drug: Buprenorphine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Buprenorphine Maintenance Treatment of Opioid Dependence in Primary Care: A Randomized Clinical Trial of At-Home Versus In-Office Buprenorphine Induction

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • The Primary Outcome Will Include a Comparison of the Proportion of Patients Successfully Inducted One Week After the Initial Primary Care Visit. [ Time Frame: one week after initial primary care visit ] [ Designated as safety issue: Yes ]
    The primary outcome will include a comparison of the proportion of patients successfully inducted one week after the initial primary care visit. Defined as in treatment, on Buprenorphine and withdrawal free.


Secondary Outcome Measures:
  • Prolonged Withdrawal [ Time Frame: a) 2 days ] [ Designated as safety issue: Yes ]
    participants experiencing prolonged withdrawal beyond two days after buprenorphine induction


Enrollment: 20
Study Start Date: December 2007
Study Completion Date: April 2010
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Unobserved-at home
Buprenorphine Unobserved at home induction
Drug: Buprenorphine
Dose is determined according to the participants' individual need.
Other Name: Bup
Active Comparator: Observed
Buprenorphine Observed in office induction
Drug: Buprenorphine
Dose is determined according to the participants' individual need.
Other Name: Bup

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 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00684554

Locations
United States, New York
Columbia University/New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Erik W Gunderson, M.D. Columbia University
  More Information

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00684554     History of Changes
Other Study ID Numbers: #5600  K23DA020000 
Study First Received: May 22, 2008
Results First Received: May 19, 2015
Last Updated: April 6, 2016
Health Authority: United States: Federal Government

Keywords provided by New York State Psychiatric Institute:
Heroin Dependence
Opioid Dependence
Primary Care
Buprenorphine

Additional relevant MeSH terms:
Heroin Dependence
Opioid-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Buprenorphine
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 03, 2016