Low-Dose Opiate Therapy for Discomfort in Dementia (L-DOT)
Condition: Alzheimer Disease; Dementia; Dementia, Vascular; Pain
MeSH terms: Alzheimer Disease; Dementia; Dementia, Vascular
Intervention: hydrocodone/APAP w placebo PRN; hydrocodone/APAP; placebo with hydrocodone/APAP PRN
Intervention description: Hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid three times daily (TID). With liquid placebo available PRN.; Participants judged as responders during Phase A continue the same dose of study medication (hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid TID). Otherwise, moved to a higher dose (hydrocodone/acetaminophen 5/500mg TID or the most appropriate formulary alternative). Participant can also receive up to 2 PRN administrations at the same dose levels as listed above, but not to exceed 2.5g of acetaminophen.; Liquid placebo PRN. Also available PRN is Hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid.
Intervention MeSH terms: Acetaminophen; Acetaminophen, hydrocodone drug combination; Hydrocodone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 11.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No
Keywords: Agitation; Alzheimer Disease; Analgesics; Dementia; Narcotics; Opioid; Pain; Palliative Care; Psychomotor; Suffering, Physical

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.
    

Eligibility criteria:

        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)