A Phase 2 interventional study of Dextromethorphan and Lidocaine in Central Neuropathic Pain, Allodynia and Spinal Cord Injury, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-12-08.
Sponsored by Brigham and Women's Hospital · Phase 2, Interventional, and Treatment
This randomized, placebo-controlled, double-blind 4x4 crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO) dextromethorphan and intravenous (IV) lidocaine in central neuropathic pain following spinal cord injury.
This trial has several objectives:
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.
166 studies on the registry are indexed under Hyperalgesia; 14 are open to participants now.
This study's enrollment of 26 is below the median of 50 across 142 interventional studies indexed under Hyperalgesia.
Browse Hyperalgesia studies →Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placebo in combination with 0mg/kg LBM lidocaine
Drug: Placebo (Dextromethorphan) · Drug: Placebo (Lidocaine)
Placebo in combination with 1mg/kg LBM lidocaine
Drug: Lidocaine · Drug: Placebo (Dextromethorphan)
Placebo in combination with 2mg/kg LBM lidocaine
Drug: Lidocaine · Drug: Placebo (Dextromethorphan)
Placebo in combination with 4mg/kg LBM lidocaine
Drug: Lidocaine · Drug: Placebo (Dextromethorphan)
Low dose dextromethorphan in combination with 0mg/kg LBM lidocaine
Drug: Dextromethorphan · Drug: Placebo (Lidocaine)
Low dose dextromethorphan in combination with 1mg/kg LBM lidocaine
Drug: Dextromethorphan · Drug: Lidocaine
Low dose dextromethorphan in combination with 2mg/kg LBM lidocaine
Drug: Dextromethorphan · Drug: Lidocaine
Low dose dextromethorphan in combination with 4mg/kg LBM lidocaine
Drug: Dextromethorphan · Drug: Lidocaine
Medium dose dextromethorphan in combination with 0mg/kg LBM lidocaine
Drug: Dextromethorphan · Drug: Placebo (Lidocaine)
Medium dose dextromethorphan in combination with 1mg/kg LBM lidocaine
Drug: Dextromethorphan · Drug: Lidocaine
Medium dose dextromethorphan in combination with 2mg/kg LBM lidocaine
Drug: Dextromethorphan · Drug: Lidocaine
Medium dose dextromethorphan in combination with 4mg/kg LBM lidocaine
Drug: Dextromethorphan · Drug: Lidocaine
High dose dextromethorphan in combination with 0mg/kg LBM lidocaine
Drug: Dextromethorphan · Drug: Placebo (Lidocaine)
High dose dextromethorphan in combination with 1mg/kg LBM lidocaine
Drug: Dextromethorphan · Drug: Lidocaine
High dose dextromethorphan in combination with 2mg/kg LBM lidocaine
Drug: Dextromethorphan · Drug: Lidocaine
High dose dextromethorphan in combination with 4mg/kg LBM lidocaine
Drug: Dextromethorphan · Drug: Lidocaine
Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD)
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)
0mg Dextromethorphan
0mg/kg LBM Lidocaine
Percent Change in Peak Pain Intensity
Primary outcome was percent change from baseline in mean pain intensity at Cmax (transformed Gracely Scale; 0-35). Higher values on the Gracely scale represent greater pain intensity; the greater the percent change from baseline in mean pain intensity, the bigger the reduction in pain intensity.
Time frame: 30 minutes post-infusion (Cmax)
Recruitment began in March 2003. Subjects were recruited nationally from referring physicians, through advertisements, and through an existing database held by the PI.
| Milestone | Dextromethorphan/Lidocaine Combination Clinical Trial |
|---|---|
| Started | 26 |
| Placebo dex v. 0mg/km lbm lidocaine | 24 |
| Placebo dex v. 1mg/km lbm lidocaine | 24 |
| Placebo dex v. 2mg/km lbm lidocaine | 24 |
| Placebo dex v. 4mg/km lbm lidocaine | 24 |
| Low dose dex v. 0mg/km lbm lidocaine | 26 |
| Low dose dex v. 1mg/km lbm lidocaine | 26 |
| Low dose dex v. 2mg/km lbm lidocaine | 26 |
| Low dose dex v. 4mg/km lbm lidocaine | 26 |
| Medium dose dex v. 0mg/km lbm lidocaine | 24 |
| Medium dose dex v. 1mg/km lbm lidocaine | 24 |
| Medium dose dex v. 2mg/km lbm lidocaine | 24 |
| Medium dose dex v. 4mg/km lbm lidocaine | 24 |
| High dose dex v. 0mg/km lbm lidocaine | 24 |
| High dose dex v. 1mg/km lbm lidocaine | 24 |
| High dose dex v. 2mg/km lbm lidocaine | 24 |
| High dose dex v. 4mg/km lbm lidocaine | 24 |
| Completed | 26 |
| Not completed | 0 |
Primary outcome was percent change from baseline in mean pain intensity at Cmax (transformed Gracely Scale; 0-35). Higher values on the Gracely scale represent greater pain intensity; the greater the percent change from baseline in mean pain intensity, the bigger the reduction in pain intensity.
| percentage change from baseline | Dextromethorphan/ 0mg/kg Lidocaine Combination | Dextromethorphan/1mg/kg Lidocaine Combination | Dextromethorphan/2mg/kg Lidocaine Combination | Dextromethorphan/4mg/kg Lidocaine Combination |
|---|---|---|---|---|
| Percent Change in Peak Pain Intensity | -2.5 ± 0.0049 | -7.9 ± 0.0176 | -11.2 ± 0.0015 | -19.2 ± 0.0226 |
Collected over Adverse event data were collected from the start of the lidocaine infusion (t=0:00) and recorded for the entire 30 minute infusion (t=0:30). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo Dextromethorphan/0mg/kg Lidocaine Combination | 0/24 (0%) | — | 4/24 (16.7%) |
| Placebo Dextromethorphan/1mg/kg Lidocaine Combination | 0/24 (0%) | 0/24 (0%) | 3/24 (12.5%) |
| Placebo Dextromethorphan/2mg/kg Lidocaine Combination | 0/24 (0%) | 0/24 (0%) | 5/24 (20.8%) |
| Placebo Dextromethorphan/4mg/kg Lidocaine Combination | 0/24 (0%) | 0/24 (0%) | 10/24 (41.7%) |
| Low Dose Dextromethorphan/0mg/kg Lidocaine Combination | 0/26 (0%) | 0/26 (0%) | 5/26 (19.2%) |
| Low Dose Dextromethorphan/1mg/kg Lidocaine Combination | 0/26 (0%) | 0/26 (0%) | 7/26 (26.9%) |
| Low Dose Dextromethorphan/2mg/kg Lidocaine Combination | 0/26 (0%) | 0/26 (0%) | 8/26 (30.8%) |
| Low Dose Dextromethorphan/4mg/kg Lidocaine Combination | 0/26 (0%) | 0/26 (0%) | 15/26 (57.7%) |
| Medium Dose Dextromethorphan/0mg/kg Lidocaine Combination | 0/24 (0%) | 0/24 (0%) | 3/24 (12.5%) |
| Medium Dose Dextromethorphan/1mg/kg Lidocaine Combination | 0/24 (0%) | 0/24 (0%) | 6/24 (25%) |
| Medium Dose Dextromethorphan/2mg/kg Lidocaine Combination | 0/24 (0%) | 0/24 (0%) | 6/24 (25%) |
| Medium Dose Dextromethorphan/4mg/kg Lidocaine Combination | 0/24 (0%) | 0/24 (0%) | 15/24 (62.5%) |
| High Dose Dextromethorphan/0mg/kg Lidocaine Combination | 0/24 (0%) | 0/24 (0%) | 3/24 (12.5%) |
| High Dose Dextromethorphan/1mg/kg Lidocaine Combination | 0/24 (0%) | 0/24 (0%) | 3/24 (12.5%) |
| High Dose Dextromethorphan/2mg/kg Lidocaine Combination | 0/24 (0%) | 0/24 (0%) | 6/24 (25%) |
| High Dose Dextromethorphan/4mg/kg Lidocaine Combination | 0/24 (0%) | 0/24 (0%) | 17/24 (70.8%) |
| Event | Placebo Dextromethorphan/0mg/kg Lidocaine Combination | Placebo Dextromethorphan/1mg/kg Lidocaine Combination | Placebo Dextromethorphan/2mg/kg Lidocaine Combination | Placebo Dextromethorphan/4mg/kg Lidocaine Combination | Low Dose Dextromethorphan/0mg/kg Lidocaine Combination | Low Dose Dextromethorphan/1mg/kg Lidocaine Combination | Low Dose Dextromethorphan/2mg/kg Lidocaine Combination | Low Dose Dextromethorphan/4mg/kg Lidocaine Combination | Medium Dose Dextromethorphan/0mg/kg Lidocaine Combination | Medium Dose Dextromethorphan/1mg/kg Lidocaine Combination | Medium Dose Dextromethorphan/2mg/kg Lidocaine Combination | Medium Dose Dextromethorphan/4mg/kg Lidocaine Combination | High Dose Dextromethorphan/0mg/kg Lidocaine Combination | High Dose Dextromethorphan/1mg/kg Lidocaine Combination | High Dose Dextromethorphan/2mg/kg Lidocaine Combination | High Dose Dextromethorphan/4mg/kg Lidocaine Combination |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sedation ComplexNervous system disorders | 3/24 | 3/24 | 5/24 | 7/24 | 5/26 | 7/26 | 7/26 | 14/26 | 3/24 | 5/24 | 4/24 | 14/24 | 3/24 | 2/24 | 6/24 | 16/24 |
| ParathesiasNervous system disorders | 0/24 | 0/24 | 0/24 | 4/24 | 0/26 | 2/26 | 3/26 | 5/26 | 0/24 | 2/24 | 0/24 | 7/24 | 0/24 | 0/24 | 2/24 | 7/24 |
| Dry mouthNervous system disorders | 0/24 | 0/24 | 0/24 | 0/24 | 2/26 | 2/26 | 2/26 | 5/26 | 0/24 | 0/24 | 0/24 | 3/24 | 2/24 | 0/24 | 2/24 | 4/24 |
| EuphoriaNervous system disorders | 1/24 | 0/24 | 0/24 | 1/24 | 0/26 | 0/26 | 0/26 | 2/26 | 0/24 | 1/24 | 0/24 | 1/24 | 0/24 | 1/24 | 1/24 | 2/24 |
| Cramping/SpasmsMusculoskeletal and connective tissue disorders | 0/24 | 0/24 | 0/24 | 0/24 | 0/26 | 0/26 | 0/26 | 0/26 | 0/24 | 0/24 | 2/24 | 2/24 | 0/24 | 0/24 | 0/24 | 0/24 |
| Age, Categorical(Participants) | Dextromethorphan/Lidocaine Combination Clinical Trial |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 25 |
| >=65 years | 1 |
| Age, Continuous(years) | Dextromethorphan/Lidocaine Combination Clinical Trial |
|---|---|
| Mean | 46.84 ± 11.32 |
| Sex: Female, Male(Participants) | Dextromethorphan/Lidocaine Combination Clinical Trial |
|---|---|
| Female | 14 |
| Male | 12 |
| Region of Enrollment(participants) | Dextromethorphan/Lidocaine Combination Clinical Trial |
|---|---|
| North America | 26 |
Plan to share: Undecided
The record gives a start of Apr 2003, a primary completion of Jan 2008 and a completion of Jan 2008. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2018, 10 years 2 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Dextromethorphan · Lidocaine
Brigham and Women's Hospital →