Cognitive Changes With Gabapentin Treatment

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

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.

Study Overview

• Status: Terminated
• Conditions: Pain; Neuralgia Peripheral
• Intervention / Treatment: Drug: Gabapentin; Diagnostic test: BTACT; Diagnostic test: BPI; Diagnostic test: HADS; Diagnostic test: SLP9; Diagnostic test: NPSI

• Study Type: Observational
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University Medical Center/Barnes-Jewish Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with neuropathic pain, who are prescribed gabapentin per standard of care

Description

Inclusion Criteria:

1. Age between 18 and 85
2. Diagnosis of neuropathic pain
3. Patient report of average daily pain intensity in the last week >3 on 0-10 Numerical Rating Scale (NRS).
4. Able and willing to sign an IRB-approved written informed consent

Exclusion Criteria:

1. Current pregabalin treatment
2. Patient has started taking a new pain medication, or has changed their pain medication dose, in the past 4 weeks.
3. Treatment with opioids exceeding 60mg MME.
4. Severe cognitive impairment that is documented in medical chart.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients with Neuropathic Pain

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Brief Test of Adult Cognition by Telephone (BTACT)	Measure of cognitive functioning that assesses multiple dimensions central for effective functioning across adulthood: episodic memory, working memory, reasoning, verbal fluency, and executive functioning. Scoring: Word List Recall - Immediate & Delayed Total number unique is total number of correct responses (range 0-15) Backward Digit Span Score is highest number of digits reached (range 0, 2-8) Category Fluency Total number unique is total number of correct responses Red/Green Accuracy Normal baseline score is total number correct in normal baseline condition (range 0-20) Number Series Total number of items correct (range 0-5) Backward Counting Last number reached Total number of errors Total number of digits produced is calculated as: 100 - (number reached + number errors)	up to 6 weeks after treatment initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain severity - BPI	Medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Center for Symptom Evaluation in Cancer Care 0-10 pain severity scale, 0=no pain, 10=pain as bad as you can imagine (scoring-a mean severity score) 0-10 pain relief scale, 0%=no relief, 100%=complete relief (only one question) 0-10 pain interference scale, 0=does not interfere, 10=completely interferes (scoring-mean of 7 items)	up to 6 weeks after treatment initiation
Change in Depression and Anxiety - HADS	Measure of anxiety and depression in a general population of patients. Popular for clinical practice and research. Score- 8-10 mild, 11-14 moderate, 15-21 severe (separate scores for anxiety and depression)	up to 6 weeks after treatment initiation
Change in Sleep Problems - SLP9	Questionnaire to evaluate problems with sleep. Scale: 1=all of the time, 2=most of the time, 3=a good bit of the time, 4=some of the time, 5=a little of the time, 6=none of the time Final scores range from 0-100, with higher scores indicating more sleep problems. To score the SPI II, you must first transform the responses of each item into a new score. For item 1, responses of 1, 2, 3, 4, and 5 are scored as 0, 25, 50, 75, and 100, respectively. For items 3 and 9, ratings of 1 through 6 are scored as 0, 20, 40, 60, 80, and 100, respectively. All of the other items are reverse-scored (lower ratings indicate more sleep difficulties) and so ratings of 1 through 6 for these items are scored as 100, 80, 60, 40, 20, and 0, respectively. The final SPI II score is an average of the item scores responded to.	up to 6 weeks after treatment initiation
Change in Neuropathic Pain - NPSI	Questionnaire to evaluate the different symptoms of neuropathic pain. 0-10 scale, 0=no sensation, 10=greatest sensation intensity	up to 6 weeks after treatment initiation

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Jessica Justmann, MD, Washington University School of Medicine

Publications and helpful links

General Publications

• Berger A, Sadosky A, Dukes E, Edelsberg J, Oster G. Clinical characteristics and patterns of healthcare utilization in patients with painful neuropathic disorders in UK general practice: a retrospective cohort study. BMC Neurol. 2012 Mar 6;12:8. doi: 10.1186/1471-2377-12-8.
• Finnerup NB, Attal N. Tapentadol prolonged release in the treatment of neuropathic pain related to diabetic polyneuropathy--authors' reply. Lancet Neurol. 2015 Jul;14(7):685-6. doi: 10.1016/S1474-4422(15)00060-5. No abstract available.
• Fleet JL, Dixon SN, Kuwornu PJ, Dev VK, Montero-Odasso M, Burneo J, Garg AX. Gabapentin dose and the 30-day risk of altered mental status in older adults: A retrospective population-based study. PLoS One. 2018 Mar 14;13(3):e0193134. doi: 10.1371/journal.pone.0193134. eCollection 2018.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 10, 2020
• Primary Completion (ACTUAL): February 18, 2021
• Study Completion (ACTUAL): February 18, 2021

Study Registration Dates

• First Submitted: September 24, 2019
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (ACTUAL): September 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 1, 2021
• Last Update Submitted That Met QC Criteria: February 24, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin
• Other Study ID Numbers: 201908050

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No