Clinical trial NCT04106011: Cognitive Changes With Gabapentin Treatment
Official title: Cognitive Changes Associated With Initiation of Gabapentin Treatment in Adults With Chronic Pain
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Neuralgia Peripheral
Pain
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with neuropathic pain, who are prescribed gabapentin per standard of care

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in the Brief Test of Adult Cognition by Telephone (BTACT)
timeFrame: up to 6 weeks after treatment initiation
Secondary outcomes:
measure: Change in pain severity - BPI
timeFrame: up to 6 weeks after treatment initiation
measure: Change in Depression and Anxiety - HADS
timeFrame: up to 6 weeks after treatment initiation
measure: Change in Sleep Problems - SLP9
timeFrame: up to 6 weeks after treatment initiation
measure: Change in Neuropathic Pain - NPSI
timeFrame: up to 6 weeks after treatment initiation
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University Medical Center/Barnes-Jewish Hospital
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Jessica Justmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. No abstract available.
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.