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

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ClinicalTrials.gov Identifier: NCT01318369
Recruitment Status : Completed
First Posted : March 18, 2011
Last Update Posted : July 9, 2013
Information provided by (Responsible Party):
Radboud University Medical Center

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.

Condition or disease Intervention/treatment Phase
Cannabinoid Tetrahydrocannabinol Chronic Pancreatitis Abdominal Pain Drug: Namisol Drug: Diazepam Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Safety, Tolerability, and Analgesic Efficacy of Δ9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain
Study Start Date : October 2011
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Arm Intervention/treatment
Experimental: Namisol
Namisol (dronabinol) single dose 8 mg
Drug: Namisol
Single dose delta-9-tetrahydrocannabinol
Other Names:
  • Dronabinol
  • THC

Active Comparator: Diazepam
Diazepam single dose 5mg in subgroup non-opioid users and 10 mg in subgroup opioid users.
Drug: Diazepam
Diazepam single dose 5mg in subgroup non-opioid users and 10 mg in subgroup opioid users.

Primary Outcome Measures :
  1. Pain intensity (VAS pain) [ Time Frame: Repeatedly; baseline until 6 hours after administration ]
    Pain intensity (VAS pain at rest and on movement)

Secondary Outcome Measures :
  1. EEG [ Time Frame: Repeatedly; baseline until 6 hours after administration ]
    Spontaneous EEG and evoked potentials to noxious electrical stimuli

  2. QST [ Time Frame: Repeatedly; baseline until 6 hours after administration ]
    Quantitative Sensory Testing, using pressure pain tolerance and electrical thresholds

  3. Body sway [ Time Frame: Repeatedly; baseline until 6 hours after administration ]
    Static body sway

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01318369

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Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University Medical Center
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Principal Investigator: Harry van Goor, MD PhD Radboud University Medical Center
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Responsible Party: Radboud University Medical Center
ClinicalTrials.gov Identifier: NCT01318369    
Other Study ID Numbers: HEEL-2011-01
First Posted: March 18, 2011    Key Record Dates
Last Update Posted: July 9, 2013
Last Verified: July 2013
Additional relevant MeSH terms:
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Pancreatitis, Chronic
Abdominal Pain
Pancreatic Diseases
Digestive System Diseases
Neurologic Manifestations
Signs and Symptoms, Digestive
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Adjuvants, Anesthesia
Autonomic Agents
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants