Trial | NCT00377468  Report issue

Title

Effect of Delta-9-Tetrahydrocannabinol on the Prevention of Chronic Pain in Patients With Acute CRPS (ETIC-Study)
Low Dose Administration of Delta9-Tetrahydrocannabinol for the Prevention of Hyperalgesia and Chronic Pain in Patients With Acute Complex Regional Pain Syndrome (CRPS) of the Upper Limb

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Indication/Condition

    CRPS ...

  • Intervention/Treatment

    dronabinol ...

  • Study Participants

    100
The purpose of this study is to determine whether application of low dose Delta9-Tetrahydrocannabinol can prevent the development of chronic pain in patients with acute CRPS.
Recent animal data suggest that the endocannabinoid system is a promising target in the prevention of chronic pain. It has been shown that the endocannabinoid system modifies excitatory and inhibitory currents in structures involved in the development of chronic pain such as the amygdala.

CRPS is a neuropathic pain condition, which is known to become chronic in a significant percentage. The study compares the effect of low dose Delta9-Tetrahydrocannabinol (90 days) and placebo in acute CRPS. All patients will receive a standard treatment consisting of drug therapy and physiotherapy.
Study Started
Sep 30
2006
Study Completion
Dec 31
2008
Anticipated
Last Update
Jun 30
2008
Estimate

Drug Delta9-Tetrahydrocannabinol

Criteria 

Inclusion Criteria:

Patients with clinical diagnosis of acute CRPS (time from inciting event less than 16 weeks) of the upper extremity
No risk of dependency in a psychological assessment

Exclusion Criteria:

History of alcohol or drug abuse
Cardiac arrhythmias
Acute or chronic renal failure
ASA physical status classification III or higher
Psychiatric disorders
Pregnancy and breast feeding
No Results Posted