Lidocaine Infusion for Chronic Pain in Opioid Dependent Patients

Stopped early · Phase 3

Conditions studied: Chronic Pain

In brief

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 non-cancer pain and are only partially effective for short-term pain relief. Whereas opioids are initially part of the solution for pain, it eventually often turns to be a problem in patient with chronic pain. Long-term treatment with opioids can be complicated by development of tolerance, dependency, addiction, abnormal pain sensitivity, hormonal changes, and immune modulation. Unfortunately, the chronic use of anti-inflammatory drugs is associated with a marked increase in adverse effects. The purpose of this study is to determine whether systemic administration of lidocaine provides effective pain relief in opioid dependent chronic pain patients. Investigators intend to demonstrate that lidocaine infusion can improve pain relief and physical function in opioid dependent patients, thus improving compliance and patient satisfaction, which may potentially help wean patients off narcotics. The long-term goal of this proposal is to decrease opioid dependence in chronic pain patients by using lidocaine infusion.

Key facts

Study ID

NCT02219321

Run by

University of Texas Southwestern Medical Center

People needed

3

Starts

2014-12-01

Expected to finish

2019-09-20

Last updated by the study team

2020-03-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Parkland Health Hospital System — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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