• Discomfort Battery(DB), Discomfort Scale for patient with Dementia Alzheimer's Type(DS-DAT) [ Time Frame: Eight (8) weeks ] [ Designated as safety issue: No ]
  

• Pain Assessment in Advanced Dementia (PAINAD) [ Time Frame: Eight (8) weeks ] [ Designated as safety issue: No ]
  
• Computer Assisted Behavior Observation System (CABOS) [ Time Frame: Eight (8) Weeks ] [ Designated as safety issue: No ]
  

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.