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

July 8, 2013 updated by: Radboud University Medical Center

The Safety, Tolerability, and Analgesic Efficacy of Δ9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500 HB
        • Radboud University Nijmegen Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Namisol
Namisol (dronabinol) single dose 8 mg
Single dose delta-9-tetrahydrocannabinol
Other Names:
  • THC
  • Dronabinol
Active Comparator: Diazepam
Diazepam single dose 5mg in subgroup non-opioid users and 10 mg in subgroup opioid users.
Diazepam single dose 5mg in subgroup non-opioid users and 10 mg in subgroup opioid users.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity (VAS pain)
Time Frame: Repeatedly; baseline until 6 hours after administration
Pain intensity (VAS pain at rest and on movement)
Repeatedly; baseline until 6 hours after administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EEG
Time Frame: Repeatedly; baseline until 6 hours after administration
Spontaneous EEG and evoked potentials to noxious electrical stimuli
Repeatedly; baseline until 6 hours after administration
QST
Time Frame: Repeatedly; baseline until 6 hours after administration
Quantitative Sensory Testing, using pressure pain tolerance and electrical thresholds
Repeatedly; baseline until 6 hours after administration
Body sway
Time Frame: Repeatedly; baseline until 6 hours after administration
Static body sway
Repeatedly; baseline until 6 hours after administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Harry van Goor, MD PhD, Radboud University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

March 9, 2011

First Submitted That Met QC Criteria

March 17, 2011

First Posted (Estimate)

March 18, 2011

Study Record Updates

Last Update Posted (Estimate)

July 9, 2013

Last Update Submitted That Met QC Criteria

July 8, 2013

Last Verified

July 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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