A Retrospective and prospective, obsErvational (non-interventional), post-authorization Safety cohort sTudy to evaluate the incidence of the breAkages and insertion/Removal complications of buprenorphine implants in rouTine clinical care (RE-START)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  SIXMO
• Study drug International non-proprietary name (INN) or common name:
  BUPRENORPHINE
• Anatomical Therapeutic Chemical (ATC) code:
  (N07BC01) buprenorphine

  buprenorphine
• Additional medical condition(s):
  Opioid dependence

Population studied

• Short description of the study population:
  Study population will consist of alive male and female patients aged 18 years or over, with a diagnosis of opioid dependence and treated with Sixmo® as part of their routine clinical care, according to the approved Summary of Product Characteristics (SmPC).
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  120

Study design details

• Study design:
  Multi-centre, retrospective and prospective cohort, observational (non-interventional) PASS
• Main study objective:
  The primary objective is:; - To describe the rate of breakage of Sixmo® implants (endpoint: all implant breakages reported as occurring during the treatment period, whether or not associated with adverse events linked to Sixmo® implant).