Δ9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain

Radboud University Medical Center

Status and phase

Completed

Phase 2

Conditions

Chronic Pain

Pancreatitis, Chronic

Abdominal Pain

Treatments

Drug: Placebo

Drug: Tetrahydrocannabinol

Study type

Interventional

Funder types

Other

Identifiers

NCT01551511

HEEL-2011-02

Details and patient eligibility

About

Abdominal pain resulting from chronic pancreatitis (CP) 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 pharmacokinetic profile, provides the opportunity to test the analgesic potential of Δ9-THC in favourable conditions. The current study aims to investigate the analgesic efficacy of Namisol® as add-on analgesic during a long-term treatment (52 days) of abdominal pain resulting from CP.

Enrollment

29 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Aged 18 years or older
Confirmed chronic pancreatitis
Pain duration exceeding 3 months, and average NRS≥3
Stable doses intake of analgesics for the past 2 months
The patient has been informed about the study, understood the information and signed the informed consent form

Exclusion criteria

Patient took cannabinoids on a regular basis for at least one year
Patient does not feel a pinprick test in the lower extremities
Patient has a body mass index (BMI) above 32,0 kg/m2
Patient suffers from serious painful conditions other than chronic pancreatitis
Patient has a significant medical disorder that may interfere with the study or may pose a risk for the patient
Patient uses any kind of concomitant medication that may interfere with the study or may pose a risk for the patient
Patient does not tolerate oral intake of medication or liquids, or is refrained from oral intake because of medical reasons
Patient demonstrates clinical relevant deviations in the electrocardiogram (ECG)
Patient has an actual moderate to severe renal impairment
Patient has an actual moderate to severe hepatic impairment
Patient has a presence or history of major psychiatric illness
Patient has experienced an epileptic seizure in the past
Patient demonstrates clinically significant laboratory abnormalities
Patient demonstrates a positive urine drug screen for THC, cocaine, MDMA, and amphetamines
Patient demonstrates a positive test result on hepatitis B surface antigen, hepatitis C antibody or HIV antibody test
Patient has a history of sensitivity / idiosyncrasy to THC
Patient has a known or suspected lactose intolerance
Female patient is pregnant or breastfeeding
Patient intends to conceive a child during the course of the study
Patient participates in another investigational drug study
Patient has a clinical significant exacerbation in illness
Patient is unwilling or unable to comply with the lifestyle guidelines