NCT01318369

Efficacy Study of Δ9-THC to Treat Chronic Abdominal Pain

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Namisol	Single dose delta-9-tetrahydrocannabinol
DRUG	Diazepam	Diazepam single dose 5mg in subgroup non-opioid users and 10 mg in subgroup opioid users.

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2011-03-18
• Last updated: 2013-07-09

Locations

1 site across 1 country: Netherlands