| City: |
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Tuscaloosa |
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State:
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AL |
| Zip Code: |
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35404 |
| Conditions: |
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Alzheimer Disease - Dementia - Dementia, Vascular - Pain |
| Purpose: |
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The purpose of this study is 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 is also known as Lortab and contains both a narcotic pain medication and the same
pain medication as contained in Tylenol. The study will also assess how well patients
tolerate this medication and will measure the impact that relief of discomfort has on
agitation and other symptoms. This study is an eight-week long clinical trial for
discomfort among veterans with advanced dementia who are admitted to a Nursing Home Care
Unit (NHCU) at the Tuscaloosa VA Medical Center.
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| Study summary: |
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OBJECTIVES: The primary objective of the Low-Dose Opiate Therapy for Discomfort in Dementia
(L-DOT) project will be 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. The secondary objectives will be to assess the tolerability of such treatment and
to assess the impact of effective analgesia on agitation and other symptom burden in this
population.
RESEARCH DESIGN: This study is a two-week double-blind, double-dummy, placebo-controlled,
crossover trial of low-dose hydrocodone/acetaminophen (Lortab) for discomfort among veterans
with a dementia, followed by six weeks of open-label therapy for patients who tolerate
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 at Tuscaloosa VAMC who demonstrate significant discomfort (as measured by the Pain
Assessment in Advanced Dementia - PAINAD) will be randomized to one of two groups, using a
double-blind, double-dummy, placebo-controlled, crossover design. Patients will be randomly
assigned to treatment with either hydrocodone/acetaminophen 2.5mg/250mg TID scheduled with
placebo TID PRN or placebo TID scheduled with hydrocodone/acetaminophen 2.5mg/250mg TID PRN.
After one week's treatment, patients will be crossed over to the other (opposite) regimen,
for a total of two weeks of blinded treatment. Patients who tolerate treatment with
hydrocodone/acetaminophen will be eligible for a six-week, open-label continuation phase.
Outcome measures will include pain/discomfort, agitation, symptom burden,
tolerability/adverse effects, and dropout rates. Preliminary sample size calculations
indicate that 42 patients (48 patients accounting for dropouts) would need 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 underrecognized and undertreated in long
term care settings. This study will 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 not been studied for this purpose in this population. |
| Criteria: |
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Inclusion Criteria:
- 55 years of age or older;
- Must have a diagnosis of dementia;
- Advanced stage of dementia demonstrated by a score of 6 or greater on the Functional
Assessment Staging (FAST) scale;
- Unable to report pain in a reliable and consistent manner;
- Have a PAINAD score of at least 2 on two consecutive assessments (separated by at
least two days) OR an average PAINAD score of at least 2 on three consecutive
assessments each separated by at least two days;
- The patient must have at least one medical condition associated with pain recorded on
the CPRS problem list.
Exclusion Criteria:
- The existence of an effective analgesia treatment regimen;
- Pain treatment related to angina or pain judged to be related to angina;
- Current pain treatment with opiates that cannot, in the opinion of the attending
physician, be discontinued without placing the patient at risk for increased pain or
opiate withdrawal;
- Current pain treatment with tramadol that cannot, in the opinion of the attending
physician, be discontinued;
- Presence of necessary drug therapy that is incompatible with or has potential for
clinically significant drug interaction with either hydrocodone or acetaminophen;
- A history of allergy, hypersensitivity, or intolerance to either hydrocodone or
acetaminophen;
- Constipation refractory to current treatment measures or a condition that would make
constipation dangerous for the patient in the opinion of the attending physician;
- The presence of liver disease, hepatic encephalopathy, or clinically significant
elevation of liver function tests (LFTs), as determined by the attending physician;
- The presence of renal failure, clinically significant renal insufficiency, or
clinically significant elevations of serum BUN or creatinine levels, as determined by
the attending physician; OR
- Evidence, based on assessment by a geriatrician, that the apparent behavioral
manifestations of discomfort are better explained by another problem (e.g., fever,
infection, dehydration, delirium, psychosis) |
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| Study is available at: |
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VA Medical Center, Tuscaloosa
Tuscaloosa, AL 35404
United States
Primary Contact:
Lori L Davis, MD AB
Email: lori.davis@va.gov
Phone: (205) 554-3819
Secondary Contact:
Jennifer A Biladeau
Email: Jennifer.Biladeau@va.gov
Phone: (205) 554-2000 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 21, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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