Cognitive Changes With Gabapentin Treatment

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04106011
• Other study ID #: 201908050
• Status: Terminated
• Start date: January 10, 2020
• Est. completion date: February 18, 2021

Study information

• Verified date: February 2021
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: February 18, 2021
• Est. primary completion date: February 18, 2021
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Neuralgia Peripheral
• Pain

Intervention

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
• BPI
Pain severity and interference at baseline using the Brief Pain Inventory
• HADS
Assessment of depression and anxiety with the Hospital Anxiety and Depression Scale
• SLP9
Assessment of Sleep
• NPSI
Assessment of neuropathic components

Locations

Country	Name	City	State
United States	Washington University Medical Center/Barnes-Jewish Hospital	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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