Efficacy Study of Δ9-THC to Treat Chronic Abdominal Pain

NCT01318369 | Completed Phase 2

• 1 other identifier: HEEL-2011-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Cannabinoid; Tetrahydrocannabinol; Chronic Pancreatitis; Abdominal Pain

Outcome Measures

Primary Outcomes (1)

• Pain intensity (VAS pain)

  Pain intensity (VAS pain at rest and on movement)

  Repeatedly; baseline until 6 hours after administration

Secondary Outcomes (3)

• EEG

  Repeatedly; baseline until 6 hours after administration

• QST

  Repeatedly; baseline until 6 hours after administration

• Body sway

  Repeatedly; baseline until 6 hours after administration

Study Arms (2)

Namisol

EXPERIMENTAL

Namisol (dronabinol) single dose 8 mg

Drug: Namisol

Diazepam

ACTIVE COMPARATOR

Diazepam single dose 5mg in subgroup non-opioid users and 10 mg in subgroup opioid users.

Drug: Diazepam

Interventions

Namisol DRUG

Single dose delta-9-tetrahydrocannabinol

Also known as: Dronabinol, THC

Namisol

Diazepam DRUG

Diazepam single dose 5mg in subgroup non-opioid users and 10 mg in subgroup opioid users.

Diazepam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

MeSH Terms

Conditions

Pancreatitis, Chronic; Abdominal Pain

Interventions

Dronabinol; Diazepam

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Harry van Goor, MD PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2011
• First Posted: March 18, 2011
• Study Start: October 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: July 9, 2013

Record last verified: 2013-07

Locations

NL (1)