Efficacy Study of Δ9-THC to Treat Chronic Abdominal Pain
NCT01318369 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2013-07-09
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
Interventions
- 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.
Sponsors & Collaborators
-
Radboud University Medical Center
lead OTHER
Principal Investigators
-
Harry van Goor, MD PhD · Radboud University Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-10-31
- Primary Completion
- 2013-05-31
- Completion
- 2013-05-31
Countries
- Netherlands
Study Locations
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