Effects of Amitriptyline for the Treatment of Pain on Driving Performance and Cognition.

Overview

The acute and subchronic effects of amitriptyline were compared to placebo in a double-blind crossover randomized study on driving ability and driving-related skills in chronic neuropathic pain patients.It was hypothesized that nocturnally administered 25 mg amitriptyline might affect driving performance negatively after acute, but not after subchronic treatment.

Full Title of Study: “Effects of Pain and the Treatment of Pain With Amitriptyline on Driving Performance, Attentional Capacity and Psychomotor Performance in Chronic Neuropathic Pain Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Double

Detailed Description

The present study was designed to determine the effects of nocturnally administered 25 mg amitriptyline, compared to placebo, after single (Day 1, acute effects) and repeated (Day 15, subchronic effects) administration on driving performance in neuropathic pain patients. In addition to the on-the-road driving test, laboratory tests measuring driving-related skills were administered. Moreover, effects of amitriptlyine on an attentional capacity task were tested using Event-Related Potentials (ERPs). It was hypothesized that nocturnally administered 25 mg amitriptyline might affect driving performance negatively after acute, but not after subchronic treatment.

Interventions

  • Drug: amitriptyline

Clinical Trial Outcome Measures

Primary Measures

  • driving parameters

Secondary Measures

  • laboratory task parameters
  • ERPs

Participating in This Clinical Trial

Inclusion Criteria

  • age, amitriptyline responder, adequately treated with amitriptyline in studied dose before study participation, pain intensity score (VAS) of at least 4 cm on a 10 cm scale, driving licence, driving experience, speak fluently Dutch, normal vision, right-handed

Exclusion Criteria

  • psychological or physical disorder other than pain(-related), other psychotropic medication use, excessive drinking or smoking, alcohol- or drug dependence, illigal drug use

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • UMC Utrecht
  • Collaborator
    • Utrecht University
  • Overall Official(s)
    • Edmund Volkerts, PhD, Principal Investigator, University of Utrecht, department of Psychopharmacology

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