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

Condition(s) targeted: Chronic Neuropathic Pain

Intervention: amitriptyline (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: UMC Utrecht

Official(s) and/or principal investigator(s):
Edmund Volkerts, PhD, Principal Investigator, Affiliation: University of Utrecht, department of Psychopharmacology

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.

Official title: Effects of Pain and the Treatment of Pain With Amitriptyline on Driving Performance, Attentional Capacity and Psychomotor Performance in Chronic Neuropathic Pain Patients

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety Study

Primary outcome: driving parameters

Secondary outcome:

laboratory task parameters

ERPs

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.

Minimum age: 30 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

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

University of Utrecht, Utrecht 3508 TB, Netherlands

Starting date: October 2002
Ending date: May 2005
Last updated: September 12, 2005