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: December 7, 2015
Last verified: December 2015

May 22, 2008
December 7, 2015
December 2007
August 2008   (final data collection date for primary outcome measure)
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.
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: No ]
Complete list of historical versions of study NCT00684554 on ClinicalTrials.gov Archive Site
Prolonged Withdrawal [ Time Frame: a) 2 days ] [ Designated as safety issue: Yes ]
participants experiencing prolonged withdrawal beyond two days after buprenorphine induction
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. [ Time Frame: a) 2 days, b) 2 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Buprenorphine Maintenance Treatment of Opioid Dependence in Primary Care: A Randomized Clinical Trial
Buprenorphine Maintenance Treatment of Opioid Dependence in Primary Care: A Randomized Clinical Trial of At-Home Versus In-Office Buprenorphine Induction
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.
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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Opioid-Related Disorders
  • Heroin Dependence
Drug: Buprenorphine
Dose is determined according to the participants' individual need.
Other Name: Bup
  • Active Comparator: Unobserved-at home
    Buprenorphine Unobserved at home induction
    Intervention: Drug: Buprenorphine
  • Active Comparator: Observed
    Buprenorphine Observed in office induction
    Intervention: Drug: Buprenorphine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
April 2010
August 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00684554
#5600, K23DA020000
No
Not Provided
Not Provided
New York State Psychiatric Institute
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Principal Investigator: Erik W Gunderson, M.D. Columbia University
New York State Psychiatric Institute
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP