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

This study has been terminated.
Sponsor:
Collaborator:
Utrecht University
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00189059
First received: September 12, 2005
Last updated: NA
Last verified: April 2005
History: No changes posted

September 12, 2005
September 12, 2005
October 2002
Not Provided
driving parameters
Same as current
No Changes Posted
  • laboratory task parameters
  • ERPs
Same as current
Not Provided
Not Provided
 
Effects of Amitriptyline for the Treatment of Pain on Driving Performance and Cognition.
Effects of Pain and the Treatment of Pain With Amitriptyline on Driving Performance, Attentional Capacity and Psychomotor Performance in Chronic Neuropathic Pain Patients

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Chronic Neuropathic Pain
Drug: amitriptyline
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
24
May 2005
Not Provided

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
Both
30 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00189059
01/341-E
Not Provided
Not Provided
UMC Utrecht
Utrecht University
Principal Investigator: Edmund Volkerts, PhD University of Utrecht, department of Psychopharmacology
UMC Utrecht
April 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP