Lidocaine Infusion for Chronic Pain in Opioid Dependent Patients

NCT02219321 | Terminated Phase 3 Results DMC

• 1 other identifier: 062014-002
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Chronic Pain

Keywords

Pain, Opioid dependence, Lidocaine infusion

Outcome Measures

Primary Outcomes (1)

• Intensity of Pain

  Visual Analog Pain Scores on a scale of 0 to 10 (0=no pain and 10=worst pain)

  Immediately after continuous 4-hours Intravenous lidocaine infusion

Secondary Outcomes (1)

• Withdrawal Time (Seconds)

  Immediately after Lidocaine Infusion

Study Arms (2)

Lidocaine infusion

ACTIVE COMPARATOR

A continuous intravenous infusion of lidocaine

Drug: Lidocaine infusion

Saline infusion

PLACEBO COMPARATOR

A continuous intravenous infusion of saline

Drug: Saline infusion

Interventions

Lidocaine infusion DRUG

Lidocaine intravenous 2mg/kg initial bolus over 5 minutes followed by a continuous intravenous infusion of lidocaine at a rate of 2mg /kg /hour for 4 hours

Also known as: Intravenous lidocaine

Lidocaine infusion

Saline infusion DRUG

A continuous intravenous infusion of saline at the same volume with lidocaine infusion for 4 hours

Also known as: Isotonic Sodium Chloride

Saline infusion

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (2)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-9068, United States

Location

Parkland Health Hospital System

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Chronic Pain; Pain; Opioid-Related Disorders

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Enas Kandil
• Organization: University of Texas Southwestern Medical Center

Enas.Kandil@UTSouthwestern.edu

214-648

Study Officials

• Enas Kandil, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asistant Professor

Study Record Dates

• First Submitted: August 14, 2014
• First Posted: August 18, 2014
• Study Start: December 1, 2014
• Primary Completion: May 14, 2015
• Study Completion: September 20, 2019
• Last Updated: March 25, 2020
• Results First Posted: March 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)