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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00377468

Enrollment

100

Registered

2006-09-18

Start date

2006-09-30

Completion date

2008-12-31

Last updated

2008-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complex Regional Pain Syndromes, CRPS

Keywords

THC, CRPS, Pain, Complex Regional Pain Syndrome, Neuropathic Pain, Chronic, Prevention

Brief summary

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.

Detailed 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.

Interventions

DRUGDelta9-Tetrahydrocannabinol

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Incidence of chronic pain at one year assessed with Visual Analogue Scale (VAS)	—

Secondary

Measure	Time frame
Changes in somatosensory phenotype at one year assessed with Quantitative Sensory Testing (QST)	—
Motor function of the affected extremity at one year assessed with a biometric evaluation	—
Changes in Health Related Quality of Life at one year assessed with SF-36	—
Changes in plasma endocannabinoid levels at 30, 60, 90 days and at one year	—

Countries

Germany

Contacts

Primary ContactMeike Lauchart, MD

Meike.Lauchart@med.uni-muenchen.de+49897095

Backup ContactVolker Huge, MD

Volker.Huge@med.uni-muenchen.de+49897095

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026