Effects of Amitriptyline for the Treatment of Pain on Driving Performance and Cognition. - Full Text View

Sponsor:	UMC Utrecht
Collaborator:	Utrecht University
Information provided by:	UMC Utrecht
ClinicalTrials.gov Identifier:	NCT00189059

Purpose

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.

Condition	Intervention	Phase
Chronic Neuropathic Pain	Drug: amitriptyline	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Placebo Control Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: 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

Resource links provided by NLM:

Drug Information available for: Amitriptyline Amitriptyline hydrochloride Triavil

U.S. FDA Resources

Further study details as provided by UMC Utrecht:

Primary Outcome Measures:

driving parameters

Secondary Outcome Measures:

laboratory task parameters
ERPs

Estimated Enrollment:	24
Study Start Date:	October 2002
Estimated Study Completion Date:	May 2005

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.

Eligibility

Ages Eligible for Study:	30 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00189059

Locations

Netherlands
University of Utrecht
Utrecht, Netherlands, 3508 TB

Sponsors and Collaborators

UMC Utrecht

Utrecht University

Investigators

Principal Investigator:

Edmund Volkerts, PhD

University of Utrecht, department of Psychopharmacology

More Information

No publications provided

Study ID Numbers:	01/341-E
Study First Received:	September 12, 2005
Last Updated:	September 12, 2005
ClinicalTrials.gov Identifier:	NCT00189059 History of Changes
Health Authority:	Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by UMC Utrecht:

neuropathic pain
erp
driving
attention
amitriptyline

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Pharmacologic Actions
Antidepressive Agents, Tricyclic

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Amitriptyline
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on March 18, 2010