Effect of Delta-9-Tetrahydrocannabinol on the Prevention of Chronic Pain in Patients With Acute CRPS (ETIC-Study)

Ludwig Maximilian University of Munich

Status and phase: Unknown; Phase 2

Conditions: Complex Regional Pain Syndromes; CRPS

Treatments: Drug: Delta9-Tetrahydrocannabinol

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT00377468

2310106

Eudra-CT: 2006-000439-85

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind