Status:
TERMINATED
Lidocaine Infusion for Chronic Pain in Opioid Dependent Patients
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Chronic Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Prescription drug abuse represents a major healthcare problem, with treatment costs reaching billions of dollars annually in the United States alone. Today opioids are commonly prescribed for chronic ...
Detailed Description
There is a significant disconnect between the escalating healthcare problem of opioid use for chronic pain, and the development of novel therapeutic strategies. A plausible strategy is to interrupt th...
Eligibility Criteria
Inclusion
- Age 18-65 years old -Patient currently on stable dose of opioids for more than six months period -
- Patients with Chronic uncontrolled neuropathic pain with documented pain score \> or = 4 despite opioids
- Not currently abusing opioids or other illicit drugs as demonstrated by history and negative urine toxicology screen
- Patient agrees to come to all follow up visits at 1, 2, and 3 week following infusion
- Having baseline/screening EKG
Exclusion
- Individuals meeting DSM-V dependence criteria for alcohol, benzodiazepine, CNS stimulant, marijuana or other drug of abuse.
- Hepatic dysfunction as determined by history and physical or clinical significant lab.
- Cardiac arrhythmias including heart block and QT prolongation as determined by history or baseline EKG.
- Subject has inability to understand and cooperate with study procedures or provide informed consent.
- Subject has history of intolerance or allergic reaction to lidocaine.
- Subject has history of seizures.
- Raynaud's disease
- Renal impairment as determined by clinically significant labs.
- Women of childbearing age who either have:
- A positive pregnancy test
- Unprotected heterosexual sex since their previous menses or;
- Not currently using and/or willing to use a medically approved form of contraception (e.g., birth control pill).
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2019
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT02219321
Start Date
December 1 2014
End Date
September 20 2019
Last Update
March 25 2020
Active Locations (2)
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1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390-9068
2
Parkland Health Hospital System
Dallas, Texas, United States, 75390