Methadone in Post-Herpetic Neuralgia Pain

Overview

Neuropathic pain is a common condition and affecting 40 to 70% of the general population. Post-herpetic neuralgia is a condition almost complex and requires a multi modal treatment. Aim: This is a pilot proof-of-principle study designed to evaluate the use of low-dose methadone in post-herpetic neuralgia patients who remained refractory after first and second line treatment for post-herpetic neuralgia (PHN) and had indication for the association of an opioid agent to their current drug regimen.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: February 2013

Interventions

  • Drug: Methadone
    • patients with post-herpetic neuralgia take methadone or placebo to treat pain symptoms.
  • Drug: Placebo
    • patients with post-herpetic neuralgia take placebo to treat the pain symptoms.

Arms, Groups and Cohorts

  • Experimental: Methadone
    • in this arm patients will take methadone 5mg.
  • Experimental: Placebo
    • in this arm patients will take placebo pills.

Clinical Trial Outcome Measures

Primary Measures

  • Change in baseline Pain
    • Time Frame: baseline (visit inclusion) and three moths latter
    • Assessing by verbal analog scale (VAS)

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with chronic (>6 months) symptomatic PHN – with visual analogical scale >40/100mm – use of first and second line drugs (tricyclic antidepressants, venlafaxine and gabapentinoids) Exclusion Criteria:

  • Don't full the criteria above

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Sao Paulo
  • Provider of Information About this Clinical Study
    • Principal Investigator: Daniel Ciampi Araujo de Andrade, MD, PhD – University of Sao Paulo

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