NCT04106011

Cognitive Changes With Gabapentin Treatment

Cognitive Changes Associated With Initiation of Gabapentin Treatment in Adults With Chronic Pain

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 3 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: —

Summary

This is a single-cohort, prospective, observational study evaluating the effects of gabapentin on cognition. The goal of the study is to determine whether there is a measurable change in cognitive function from baseline in patients who are prescribed gabapentin for the treatment of neuropathic pain.

Conditions

• Neuralgia Peripheral
• Pain

Interventions

Type	Name	Description
DRUG	Gabapentin	Titration of gabapentin will be standardized as 300mg QHS and increased by 300mg every 3 days until taking 1200mg TID or maximum tolerable dose. Subjects will undergo cognitive evaluation prior to initiation of the medication, at 1 week (when titrated to approximately 900mg/day), 3 weeks (when titrated to approximately 2100mg/day), and at 6 weeks (when titrated to 3600mg/day or maximum tolerable dose).
DIAGNOSTIC_TEST	BTACT	Cognition measure: Brief Test of Adult Cognition by Telephone
DIAGNOSTIC_TEST	BPI	Pain severity and interference at baseline using the Brief Pain Inventory
DIAGNOSTIC_TEST	HADS	Assessment of depression and anxiety with the Hospital Anxiety and Depression Scale
DIAGNOSTIC_TEST	SLP9	Assessment of Sleep
DIAGNOSTIC_TEST	NPSI	Assessment of neuropathic components

Timeline

• Start date: 2020-01-10
• Primary completion: 2021-02-18
• Completion: 2021-02-18
• First posted: 2019-09-26
• Last updated: 2021-03-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study