Efficacy Study of Δ9-THC to Treat Chronic Abdominal Pain (Delta-pain)
This study is currently recruiting participants.
Verified February 2012 by Radboud University
Sponsor:
Radboud University
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01318369
First received: March 9, 2011
Last updated: February 15, 2012
Last verified: February 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cannabinoid Tetrahydrocannabinol Chronic Pancreatitis Abdominal Pain |
Drug: Namisol |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | The Safety, Tolerability, and Analgesic Efficacy of Δ9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain |
Resource links provided by NLM:
Further study details as provided by Radboud University:
Primary Outcome Measures:
- Pain intensity (VAS pain) [ Time Frame: Repeatedly; baseline until 6 hours after administration ] [ Designated as safety issue: No ]Pain intensity (VAS pain at rest and on movement)
Secondary Outcome Measures:
- EEG [ Time Frame: Repeatedly; baseline until 6 hours after administration ] [ Designated as safety issue: No ]Spontaneous EEG and evoked potentials to noxious electrical stimuli
- QST [ Time Frame: Repeatedly; baseline until 6 hours after administration ] [ Designated as safety issue: No ]Quantative Sensory Testing, using pressure pain tolerance and electrical thresholds
- Body sway [ Time Frame: Repeatedly; baseline until 6 hours after administration ] [ Designated as safety issue: Yes ]Static body sway
| Estimated Enrollment: | 24 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Namisol
Single dose delta-9-tetrahydrocannabinol
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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 is insulin dependent for more than 5 years 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. BMI (kg/m²) = weight (kg) / (height * height) (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 gets enteral feeding.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01318369
Contacts
| Contact: Marjan de Vries, MSc | 0031 243610903 | m.devries@chir.umcn.nl |
Locations
| Netherlands | |
| Radboud University Nijmegen Medical Centre | Recruiting |
| Nijmegen, Gelderland, Netherlands, 6500 HB | |
| Contact: Marjan de Vries, MSc 0031243610903 m.devries@chir.umcn.nl | |
Sponsors and Collaborators
Radboud University
Investigators
| Principal Investigator: | Harry van Goor, MD PhD | Radboud University |
More Information
No publications provided
| Responsible Party: | Radboud University |
| ClinicalTrials.gov Identifier: | NCT01318369 History of Changes |
| Other Study ID Numbers: | HEEL-2011-01 |
| Study First Received: | March 9, 2011 |
| Last Updated: | February 15, 2012 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Additional relevant MeSH terms:
|
Abdominal Pain Pancreatitis Pancreatitis, Chronic Pain |
Signs and Symptoms Signs and Symptoms, Digestive Pancreatic Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013