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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01318369
First received: March 9, 2011
Last updated: July 8, 2013
Last verified: July 2013
  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
Drug: Diazepam
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

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 ]
    Quantitative 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


Enrollment: 24
Study Start Date: October 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01318369

Locations
Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands, 6500 HB
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: July 8, 2013
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
Diazepam
Tetrahydrocannabinol
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Muscle Relaxants, Central
Neuromuscular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators

ClinicalTrials.gov processed this record on April 15, 2014