Efficacy Study of Δ9-THC to Treat Chronic Abdominal Pain

NCT ID: NCT01318369

Last Updated: 2013-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-05-31

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.

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.

Conditions

Cannabinoid; Tetrahydrocannabinol; Chronic Pancreatitis; Abdominal Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Namisol

Namisol (dronabinol) single dose 8 mg

Group Type: EXPERIMENTAL

Namisol

Intervention Type: DRUG

Single dose delta-9-tetrahydrocannabinol

Diazepam

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

Group Type: ACTIVE_COMPARATOR

Diazepam

Intervention Type: DRUG

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

Interventions

Namisol

Single dose delta-9-tetrahydrocannabinol

Intervention Type: DRUG

Diazepam

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

Intervention Type: DRUG

Other Intervention Names

Dronabinol; THC

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harry van Goor, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, Netherlands

Countries

Netherlands

Other Identifiers

HEEL-2011-01

Identifier Type: -

Identifier Source: org_study_id