Eine nicht-interventionelle, offene, prospektive Studie zur Beurteilung des Einflusses und der Sicherheit eines ausgewogenen (10mg:10mg) THC/CBD-Extrakts auf die Schlafqualität und Schmerzempfindung bei chronischen Schmerzpatient/innen. (IMprovement of sleep in PAin patients under Cannabis Treatment) (IMPACT)

Study type

• Study type:
  Non-interventional study

Non-interventional study

• Non-interventional study design:
  Cohort

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  100

Study design details

• Main study objective:
  Effect of insomnia in chronic pain patients: Relative improvement on the "Regensburger Insomnie Skala" (RIS, sum of points) versus baseline of 30% at minimum. AND/OR Absolute RIS-Verbesserung (sum of points) versus baseline by minimal 5 (minimal clinically important diffeerence, MCID).
• Outcomes:
  Effect of insomnia in chronic pain patients: Relative improvement on the "Regensburger Insomnie Skala" (RIS, sum of points) versus baseline of 30% at minimum. AND/OR Absolute RIS-Verbesserung (sum of points) versus baseline by minimal 5 (minimal clinically important diffeerence, MCID). 1. Effect of THC/CBD on pain intensity (Reduction of mean pain intensity): 2. Evaluation of safety and tolerability of THC/CBD. 3. Effect of THC/CBD on Co-medication / reduction of polypharmacy.
• Data analysis plan:
  No formal sample size calculation is performed for this exploratory study. Therefore, the interpretation of the change in sleep quality and pain perception will be modelled with a focus on effect size and confidence intervals to account for statistical error parameters. Exploratory analyses will be conducted for all patients participating in the study. Special (exploratory) subgroup analyses of interest are e.g. pain indication, gender. For univariate descriptive statistics, continuous data are summarised by sample size, mean, standard deviation, median and range, using additional descriptors where appropriate. Categorical data are counted by number and percentage of participants.