Low-Dose Opiate Therapy for Discomfort in Dementia (L-DOT) (LDOT)
Alzheimer Disease, Dementia, Dementia, Vascular
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring Agitation, Alzheimer Disease, Analgesics, Dementia, Narcotics, Opioid, Pain, Palliative Care, Psychomotor, Suffering, Physical
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)
Sites / Locations
- Tuscaloosa VA Medical Center
- Tuscaloosa Veterans Affairs Medical Center
- VA Medical Center, Tuscaloosa
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Placebo Comparator
Active Comparator
A1: hydrocodone/APAP w placebo PRN
A2: placebo w hydrocodone/APAP PRN
B: Open label hydrocodone/acetaminophen
This is a fully crossed study, each participant serves as his own control. Phase A (closed label) has two arms: A1 is the experimental and A2 is the placebo comparator. Participants are randomized to either A1 for 1 week then A2 for 1 week OR A2 for 1 week then A1 for one week. A1: hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid TID, with liquid placebo available PRN. A2: liquid placebo TID with hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid PRN.
This is a fully crossed study, each participant serves as his own control. Phase A: Participants are randomized to either A1 for 1 week then A2 for 1 week OR A2 for 1 week then A1 for one week. A1: hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid TID, with liquid placebo available PRN. A2: liquid placebo TID with hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid PRN.
Phase B: If tolerated study medication during Phase A (i.e., the closed label, double-blind phase of the trial) then enter a six-week, open-label phase. Participants judged as responders during Phase A continue the same dose of study medication. 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.