Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan/Lidocaine Combination Clinical Trial
NCT ID: NCT02218203
Last Updated: 2025-12-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
26 participants
INTERVENTIONAL
2003-04-30
2008-01-31
Brief Summary
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Detailed Description
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Primary Objective To determine which combination (dose-ratio) of dextromethorphan and lidocaine provides the best balance of pain reduction and toxicity.
Secondary Objectives include To evaluate the analgesic efficacy of both dextromethorphan and lidocaine in attenuating pain related to central nervous system sensitization, specifically spontaneous pain, mechanical allodynia, and hyperalgesia.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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Placebo- 0mg/kg Lido
Placebo in combination with 0mg/kg LBM lidocaine
Placebo (Dextromethorphan)
0mg Dextromethorphan
Placebo (Lidocaine)
0mg/kg LBM Lidocaine
Placebo - 1mg/kg Lido
Placebo in combination with 1mg/kg LBM lidocaine
Lidocaine
0mg, 1mg, 2mg, and 4mg Lidocaine per kg of lean body mass (LBM), during each of the 4 dextromethorphan periods (placebo, low dose, medium dose, and high dose)
Placebo (Dextromethorphan)
0mg Dextromethorphan
Placebo - 2mg/kg Lido
Placebo in combination with 2mg/kg LBM lidocaine
Lidocaine
0mg, 1mg, 2mg, and 4mg Lidocaine per kg of lean body mass (LBM), during each of the 4 dextromethorphan periods (placebo, low dose, medium dose, and high dose)
Placebo (Dextromethorphan)
0mg Dextromethorphan
Placebo - 4mg/kg Lido
Placebo in combination with 4mg/kg LBM lidocaine
Lidocaine
0mg, 1mg, 2mg, and 4mg Lidocaine per kg of lean body mass (LBM), during each of the 4 dextromethorphan periods (placebo, low dose, medium dose, and high dose)
Placebo (Dextromethorphan)
0mg Dextromethorphan
Low Dose Dex - 0mg/kg Lido
Low dose dextromethorphan in combination with 0mg/kg LBM lidocaine
Dextromethorphan
Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD)
Placebo (Lidocaine)
0mg/kg LBM Lidocaine
Low Dose Dex - 1mg/kg Lido
Low dose dextromethorphan in combination with 1mg/kg LBM lidocaine
Dextromethorphan
Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD)
Lidocaine
0mg, 1mg, 2mg, and 4mg Lidocaine per kg of lean body mass (LBM), during each of the 4 dextromethorphan periods (placebo, low dose, medium dose, and high dose)
Low Dose Dex - 2mg/kg Lido
Low dose dextromethorphan in combination with 2mg/kg LBM lidocaine
Dextromethorphan
Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD)
Lidocaine
0mg, 1mg, 2mg, and 4mg Lidocaine per kg of lean body mass (LBM), during each of the 4 dextromethorphan periods (placebo, low dose, medium dose, and high dose)
Low Dose Dex - 4mg/kg Lido
Low dose dextromethorphan in combination with 4mg/kg LBM lidocaine
Dextromethorphan
Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD)
Lidocaine
0mg, 1mg, 2mg, and 4mg Lidocaine per kg of lean body mass (LBM), during each of the 4 dextromethorphan periods (placebo, low dose, medium dose, and high dose)
Medium Dose Dex - 0mg/kg Lido
Medium dose dextromethorphan in combination with 0mg/kg LBM lidocaine
Dextromethorphan
Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD)
Placebo (Lidocaine)
0mg/kg LBM Lidocaine
Medium Dose Dex - 1mg/kg Lido
Medium dose dextromethorphan in combination with 1mg/kg LBM lidocaine
Dextromethorphan
Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD)
Lidocaine
0mg, 1mg, 2mg, and 4mg Lidocaine per kg of lean body mass (LBM), during each of the 4 dextromethorphan periods (placebo, low dose, medium dose, and high dose)
Medium Dose Dex - 2mg/kg Lido
Medium dose dextromethorphan in combination with 2mg/kg LBM lidocaine
Dextromethorphan
Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD)
Lidocaine
0mg, 1mg, 2mg, and 4mg Lidocaine per kg of lean body mass (LBM), during each of the 4 dextromethorphan periods (placebo, low dose, medium dose, and high dose)
Medium Dose Dex - 4mg/kg Lido
Medium dose dextromethorphan in combination with 4mg/kg LBM lidocaine
Dextromethorphan
Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD)
Lidocaine
0mg, 1mg, 2mg, and 4mg Lidocaine per kg of lean body mass (LBM), during each of the 4 dextromethorphan periods (placebo, low dose, medium dose, and high dose)
High Dose Dex - 0mg/kg Lido
High dose dextromethorphan in combination with 0mg/kg LBM lidocaine
Dextromethorphan
Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD)
Placebo (Lidocaine)
0mg/kg LBM Lidocaine
High Dose Dex - 1mg/kg Lido
High dose dextromethorphan in combination with 1mg/kg LBM lidocaine
Dextromethorphan
Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD)
Lidocaine
0mg, 1mg, 2mg, and 4mg Lidocaine per kg of lean body mass (LBM), during each of the 4 dextromethorphan periods (placebo, low dose, medium dose, and high dose)
High Dose Dex - 2mg/kg Lido
High dose dextromethorphan in combination with 2mg/kg LBM lidocaine
Dextromethorphan
Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD)
Lidocaine
0mg, 1mg, 2mg, and 4mg Lidocaine per kg of lean body mass (LBM), during each of the 4 dextromethorphan periods (placebo, low dose, medium dose, and high dose)
High Dose Dex - 4mg/kg Lido
High dose dextromethorphan in combination with 4mg/kg LBM lidocaine
Dextromethorphan
Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD)
Lidocaine
0mg, 1mg, 2mg, and 4mg Lidocaine per kg of lean body mass (LBM), during each of the 4 dextromethorphan periods (placebo, low dose, medium dose, and high dose)
Interventions
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Dextromethorphan
Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD)
Lidocaine
0mg, 1mg, 2mg, and 4mg Lidocaine per kg of lean body mass (LBM), during each of the 4 dextromethorphan periods (placebo, low dose, medium dose, and high dose)
Placebo (Dextromethorphan)
0mg Dextromethorphan
Placebo (Lidocaine)
0mg/kg LBM Lidocaine
Eligibility Criteria
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Inclusion Criteria
2. Subjects used no medication or a stabilized medication regimen for chronic and well-controlled medical conditions
3. Serum laboratory examination obtained at study entry:
4. Normal cognitive function.
5. Signed informed consent.
Exclusion Criteria
2. Renal or hepatic dysfunction.
3. Significant cardiac disease (e.g. MI within 1 year).
4. Signs or symptoms of central neurological disorder, excluding SCI.
5. Severe psychological disorder requiring treatment.
6. History of hypersensitivity or intolerance to dextromethorphan or lidocaine.
7. Participation in a study of an investigational drug or device within 30 days prior to screening for this study.
18 Years
70 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Brigham and Women's Hospital
OTHER
Responsible Party
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Christine N. Sang, MD, MPH
Director, Translational Pain Research
Principal Investigators
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Christine N. Sang, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Translational Pain Research, Brigham and Women's Hospital (Disclosure: Patent)
Locations
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Translational Pain Research, Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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Related Links
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Translational Pain Research, Brigham and Women's Hospital
Other Identifiers
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2000p001387
Identifier Type: -
Identifier Source: org_study_id
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