Efficacy Study of Δ9-THC to Treat Chronic Abdominal Pain

NCT01318369 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2013-07-09

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01318369 on ClinicalTrials.gov