Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00385684
Status:
COMPLETED
Last Update Posted:
2015-11-20
First Post:
2006-10-06
Brief Title:
Low-Dose Opiate Therapy for Discomfort in Dementia L-DOT
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Low-Dose Opiate Therapy for Discomfort in Dementia L-DOT
Status:
COMPLETED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LDOT
Brief Summary:
The purpose of this study was to determine whether a low dose an opiate pain medication is effective for the treatment of discomfort in patients with advanced dementia The study medication was also known as Lortab and contained both a narcotic pain medication and acetaminophen the same pain medication as contained in Tylenol This study was an eight-week long clinical trial for discomfort among veterans with advanced dementia who were admitted to a Nursing Home Care Unit NHCU at the Tuscaloosa VA Medical Center
Detailed Description:
OBJECTIVES The primary objective of the Low-Dose Opiate Therapy for Discomfort in Dementia L-DOT project was to determine whether low-dose opiates are effective and well tolerated for the treatment of pain as manifest by discomfort in patients with advanced dementia
RESEARCH DESIGN This study was a two-week double-blind double-dummy placebo-controlled crossover trial of low-dose hydrocodoneacetaminophen Lortab for discomfort among veterans with a dementia followed by six weeks of open-label therapy for patients who tolerated treatment during the first two weeks eight weeks total treatment on study
METHODOLOGY After consent patients over age 55 with dementia residing in a nursing home care unit or at home who receive care at Tuscaloosa VAMC who demonstrate significant discomfort as measured by the Pain Assessment in Advanced Dementia - PAINAD were randomized to one of two groups using a double-blind double-dummy placebo-controlled crossover design Patients were randomly assigned to treatment with either hydrocodoneacetaminophen 25mg250mg q8hrs scheduled with placebo q8hrs PRN or placebo q8hrs scheduled with hydrocodoneacetaminophen 25mg250mg q8hrs PRN After one weeks treatment patients were crossed over to the other opposite regimen for a total of two weeks of blinded treatment Patients who tolerated treatment with hydrocodoneacetaminophen were eligible for a six-week open-label continuation phase The primary outcome measure was paindiscomfort Preliminary sample size calculations indicated that 42 patients 48 patients accounting for dropouts would be needed to be enrolled over three years to detect a difference between treatments with power of 80 and two-tailed alpha of 05
SIGNIFICANCE There is evidence that pain is both under recognized and undertreated in long term care settings This study hoped to make a significant contribution to the evidence base for a common and problematic situation among veterans with advanced dementia Advances in pain and symptom control are central to the improvement of palliative care intervention for dementia patients Low-dose opiates are the logical next category of analgesics to consider but have been rarely studied for this purpose in this population
RESEARCH DESIGN This study was a two-week double-blind double-dummy placebo-controlled crossover trial of low-dose hydrocodoneacetaminophen Lortab for discomfort among veterans with a dementia followed by six weeks of open-label therapy for patients who tolerated treatment during the first two weeks eight weeks total treatment on study
METHODOLOGY After consent patients over age 55 with dementia residing in a nursing home care unit or at home who receive care at Tuscaloosa VAMC who demonstrate significant discomfort as measured by the Pain Assessment in Advanced Dementia - PAINAD were randomized to one of two groups using a double-blind double-dummy placebo-controlled crossover design Patients were randomly assigned to treatment with either hydrocodoneacetaminophen 25mg250mg q8hrs scheduled with placebo q8hrs PRN or placebo q8hrs scheduled with hydrocodoneacetaminophen 25mg250mg q8hrs PRN After one weeks treatment patients were crossed over to the other opposite regimen for a total of two weeks of blinded treatment Patients who tolerated treatment with hydrocodoneacetaminophen were eligible for a six-week open-label continuation phase The primary outcome measure was paindiscomfort Preliminary sample size calculations indicated that 42 patients 48 patients accounting for dropouts would be needed to be enrolled over three years to detect a difference between treatments with power of 80 and two-tailed alpha of 05
SIGNIFICANCE There is evidence that pain is both under recognized and undertreated in long term care settings This study hoped to make a significant contribution to the evidence base for a common and problematic situation among veterans with advanced dementia Advances in pain and symptom control are central to the improvement of palliative care intervention for dementia patients Low-dose opiates are the logical next category of analgesics to consider but have been rarely studied for this purpose in this population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None