Status:
COMPLETED
Low-Dose Opiate Therapy for Discomfort in Dementia (L-DOT)
Lead Sponsor:
VA Office of Research and Development
Conditions:
Alzheimer Disease
Dementia
Eligibility:
All Genders
55+ years
Phase:
PHASE4
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 k...
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00385684
Start Date
October 1 2007
End Date
June 1 2014
Last Update
November 20 2015
Active Locations (3)
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1
Tuscaloosa VA Medical Center
Tuscaloosa, Alabama, United States, 35404
2
Tuscaloosa Veterans Affairs Medical Center
Tuscaloosa, Alabama, United States, 35404
3
VA Medical Center, Tuscaloosa
Tuscaloosa, Alabama, United States, 35404