Conditions: Central Neuropathic Pain Allodynia Spinal Cord Injury
Keywords: chronic pain central neuropathic pain spinal cord injury dextromethorphan lidocaine combination therapy analgesia
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 26
Healthy volunteers: no

Brief summary:
This randomized, placebo-controlled, double-blind 4x4 crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of three doses of chronic oral (PO) dextromethorphan compared to placebo in central neuropathic pain following spinal cord injury. Subjects' maximally tolerated doses (MTD) were first determined to establish individual dose-analgesic response relationships in a run-in period; following a washout period, subjects were then randomized to receive an order of four doses of dextromethorphan (including placebo) in a 4x4 Latin square cross-over design.

Detailed description:

Arms:
arm 1: 0% MTD Dextromethorphan arm 2: 25% MTD Dextromethorphan arm 3: 50% MTD Dextromethorphan arm 4: 100% MTD Dextromethorphan

Interventions: intervention 1: Dextromethorphan
Intervention descriptions: intervention 1: 0, 25, 50 and 100% of maximum tolerated dose, each administered over a 4 week period

Protocol document: