Efficacy Study of Δ9-THC to Treat Chronic Abdominal Pain (Delta-pain)

This is an interventional treatment trial for Cannabinoid Read More

Inclusion Criteria:

• Patient has chronic pancreatitis, diagnosed using the Marseille and Cambridge Classification System (addendum II).37
• Patient suffers from chronic abdominal pain typical for pancreatitis, meet the criteria for chronic pain according ISAP (intermittent or persistent pain on a daily basis in at least 3 months)38, and consider their pain must as severe enough for medical treatment (average NRS ≥ 3).
• Patient in the opioid group takes stable doses of opioids, e.g. morphine or tramadol, for the past 2 months on the day of screening. Stable dose intake is defined as a daily equivalent sum of opioid intake according medical prescription within a small deviation range as judged by the (principal) investigator.
• Patient in the non-opioid group does not take any opioids for the past 2 months on the day of screening.

Exclusion Criteria:

• Patient used any cannabinoid (by smoking cannabis or oral intake) for at least one year on the day of screening.
• Patient does not feel a pinprick test in the lower extremities, due to affected sensory input (e.g. neuropathy as a result of diabetes mellitus).
• Patient has a body mass index (BMI) below 18 or above 31.2 kg/m2.
• Patient suffers from serious painful conditions other than chronic pancreatitis or had any major pre-existing chronic pain syndrome.
• Patient has a (history of) a significant medical disorder that, in the opinion of the investigator, may interfere with the study or may pose a risk for the patient.
• Patient uses any kind of concomitant medication that, in the opinion of the investigator, may interfere with the study or may pose a risk for the patient (e.g. HIV antivirals).
• Patient takes amitriptyline on a daily basis.
• Patient takes more than 20 mg benzodiazepines 6 hours prior or following intake of study medication (11 hour am) according prescription.