Buprenorphine Maintenance Treatment of Opioid Dependence in Primary Care: A Randomized Clinical Trial
Condition: Opioid-Related Disorders; Heroin Dependence
MeSH terms: Opioid-Related Disorders; Heroin Dependence
Study type: Interventional
Phase: Phase 2/Phase 3

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 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.
    

Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention description(s): Dose is determined according to the participants' individual need.
Other intervention name(s): Bup
Intervention MeSH terms: Buprenorphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Heroin Dependence; Opioid Dependence; Primary Care; Buprenorphine