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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00189059

Enrollment

Registered

2005-09-16

Start date

2002-10-31

Completion date

2005-05-31

Last updated

2005-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Neuropathic Pain

Keywords

neuropathic pain, erp, driving, attention, amitriptyline

Brief summary

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.

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

DRUGamitriptyline

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

30 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
driving parameters	—

Secondary

Measure	Time frame
laboratory task parameters	—
ERPs	—

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026