Clinical trial NCT01318369: Efficacy Study of Δ9-THC to Treat Chronic Abdominal Pain
Official title: The Safety, Tolerability, and Analgesic Efficacy of Δ9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cannabinoid
Tetrahydrocannabinol
Chronic Pancreatitis
Abdominal Pain
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2011-03-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The main goal of this trial is to study the efficacy of Namisol® after a single dose of Δ9-THC in the treatment of pain resulting from chronic pancreatitis. Objective measures of pain processing, e.g. encephalography (EEG) and quantitative sensory testing (QST), are included to provide insight in underlying nociceptive processing.

Detailed description: The most important symptom in chronic pancreatitis (CP) is abdominal pain. Pancreatic pain is often recurrent, intense and long-lasting, and is extremely difficult to treat. Medical analgesic therapy is considered as first choice in pain management of CP, resulting in regularly prescription of opioids. The adverse consequences of prolonged opioid use, including addiction, tolerance and opioid induced hyperalgesia, call for an alternative medical treatment. Cannabis has been used to treat pain for many centuries. Delta-9-tetrahydrocannabinol (Δ9-THC), the psychoactive substance of the cannabis plant, has been shown in previous studies to be a promising analgesic. The development of Namisol®, a tablet containing purified Δ9-THC showing an improved and reliable pharmacokinetic profile, provides the opportunity to test the analgesic potential of Δ9-THC in favourable conditions.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain intensity (VAS pain)
timeFrame: Repeatedly; baseline until 6 hours after administration
Secondary outcomes:
measure: EEG
timeFrame: Repeatedly; baseline until 6 hours after administration
measure: QST
timeFrame: Repeatedly; baseline until 6 hours after administration
measure: Body sway
timeFrame: Repeatedly; baseline until 6 hours after administration
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Harry van Goor, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: