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 type:
  Non-interventional study

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  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).