Observational study to evalute patient satisfaction with different oral cannabis products
- Conditions
- Patients (cannabis-naïve / cannabis-experienced) with a diagnosed disease for which medical cannabis is indicated in the sense of the Cannabis as Medicine (CAM) Act.
- Registration Number
- DRKS00032743
- Lead Sponsor
- Avextra Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 500
1. Patients of any gender and ethnicity aged 18 years or older (both cannabis-naïve and cannabis-experienced).
2. Documented diagnosis of a condition for which cannabis as a medicine (CAM) is indicated (and has been and is being used according to the 2022 BfArM companion survey), e.g. for (but not limited to):
- Chronic musculoskeletal pain
- Neuropathic pain
- Chronic tumour-related pain
- Use in palliative care (e.g. inappetence, nausea, pain)
- Spasticity, e.g. caused by multiple sclerosis
- anorexia
- Gastrointestinal diseases (e.g. Crohn's disease, ulcerative colitis)
- Sleep disorders
- Psychiatric diseases (e.g. ADHD, tic disorder, PTSD)
- Neurological diseases (e.g. epilepsy, restless legs syndrome)
- Headaches (migraine, cluster headache, tension headache)
- Chronic lower abdominal pain (e.g. endometriosis)
3. Treatment with a cannabinoid justified on the basis of a justified assessment by the physician, weighing of the expected side effects and taking into account the state of the disease.
1. Any other condition, disorder or observation which, in the opinion of the investigator, would interfere with the participant's ability to complete the study survey.
2. Hypersensitivity/allergy to THC or CBD or the other components of the respective dosage form.
3. Psychiatric illness related to schizophrenia/psychosis.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effect of oral cannabinoid therapy on symptom burden of the patient measured by the achievement of the personal goal with cannabis therapy AND/OR improvement of individual symptoms. <br>Patient satisfaction questionnaire is filled in at all interview points<br>(as well as at treatment discontinuation).<br>Comparison between treatment groups: Baseline vs. survey time point 2 (after 1 month), survey time point 3 (after 3 months) and survey time point 4 (optional: after 6 months).
- Secondary Outcome Measures
Name Time Method