Proof of Efficacy, Maintenance of Efficacy, Long-term Safety and Investigation of the Potential for Dependence and Abuse and the Effect of Abrupt Drug Withdrawal of VER-01 in the Treatment of Patients With Chronic Non-specific Low Back Pain

Exclusion criteria

• 1. Professional groups for which the ability to operate machinery and drive vehicles is the primary activity (including truck, bus and forklift drivers, pilots) 2. Alcohol/drug/medication abuse and previous or current intake of methadone in the patient's medical history or suspected by the investigator 3. Intake of analgesic medication (non-opioid and opioid analgesics as well as adjuvant analgesics) within seven days prior to the start of the study 4. Taking cannabis-based products within 30 days prior to the start of the study 5. HIV, dementia (which impairs the assessment of symptoms) 6. Severe forms of the following diseases: Anaemia,hematological/autoimmune/endocrinal/ renal/hepatic/respiratory/cardiovascular or gastrointestinal diseases, symptomatic peripheral vascular diseases 7. Cardiovascular event in the past three months, poorly managed high blood pressure, untreated hypothyroidism, patients with Crigler-Najjar syndrome or Rotor syndrome, surgery within the past two months 8. Severe mental illnesses (e.g. psychosis, schizophrenia, bipolar disorder), severe depression that is not due to the chronic non-specific low back pain, or individuals at risk of suicide (examined using the MINI questionnaire) 9. Severe mental illness (psychosis, schizophrenia, bipolar disorder, severe depression, anxiety disorder) in a first-degree relative (parents and children); suicide in a first-degree relative (parents and children) 10. Patients with an active cancer or tumor-related pain or severe pain due to physical injury 11. Other painful comorbidities, excluding low back pain, that could interfere with the patient's evaluation during the study or the assessment of pain 12. Well-known strong adverse events in connection with cannabis consumption before the start of the study 13. Known allergy to cannabis and/or sesame seeds and products derived from them 14. Known hypersensitivity to the ingredients of the rescue medication 15. Planned blood donation, planned sperm or egg donation, planned freezing of eggs or sperm 16. Pregnancy, breastfeeding, desire to have children (within the next 20 months) 17. Participation in another clinical trial within the past 30 days before the start of the study 18. Inability to give consent, care dependency, patient has a legal guardian/caregiver, or is immobile 19. The patient is in need of special protection (e.g., incarcerated; institutionalized by a court or judicial authority; in a dependent or employment relationship with the sponsor, an external service provider of the sponsor (who is involved in the study conduct), the investigator, or the study site). Additional for Phase A: a1. In the case of a current non-drug therapy (e.g. physical or behavioural therapy, acupuncture,massage, thermotherapy), which significantly modulates the perception of pain, it was not maintained unchanged for at least eight weeks prior to study participation in Phase A. Additional for Phase D d1. Intake of additional analgesic medication (non-opioid and opioid analgesics as well as adjuvant analgesics) within 21 days prior to the start of study Phase D (except rescue medication). d2. In the case of a current non-drug therapy (e.g. physical or behavioural therapy, acupuncture,massage, thermotherapy) that significantly modulates the perception of pain, it was not maintained unchanged for at least nine weeks prior to the start of study Phase D.