Low-Dose Opiate Therapy for Discomfort in Dementia (L-DOT)

Completed · Phase 4 · Has a placebo group

Conditions studied: Alzheimer Disease, Dementia, Dementia, Vascular, Pain

In brief

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.

Key facts

Study ID

NCT00385684

Run by

VA Office of Research and Development

People needed

11

Starts

2007-10-01

Expected to finish

2014-06-01

Last updated by the study team

2015-11-20

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• Tuscaloosa VA Medical Center — Tuscaloosa, Alabama, United States
• Tuscaloosa Veterans Affairs Medical Center — Tuscaloosa, Alabama, United States
• VA Medical Center, Tuscaloosa — Tuscaloosa, Alabama, United States

Full record on ClinicalTrials.gov

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