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LDOT

CompletedPhase 4Results posted

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

Lead sponsor

VA Office of Research and Development

Asset

hydrocodone/APAP

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age ≥55

Primary endpoint

•Pain Assessment in Advanced Dementia (PAINAD)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDF4483-I

NCT IDNCT00385684

Timeline

Milestones

Study first posted2006-10-11estimated

Study start2007-10 (month precision)

Primary completion2011-12actual (month precision)

Study completion2014-06actual (month precision)

Last update posted2015-11-20estimated

Results first posted2015-11-20estimated

Assets

Drug assets

hydrocodone/APAP

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

SexAll

Healthy volunteersNot accepted

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)

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Other (unclassified)

4 endpoints

Primary/protocol endpoint/low confidence

Pain Assessment in Advanced Dementia (PAINAD)

Time frame:Two (2) weeks

descriptive

Primary/registry result/low confidence

Pain Assessment in Advanced Dementia (PAINAD)

Time frame:Two (2) weeks

descriptive

Posted result

Group	Value (mean), units on a scale	Standard deviation
Experimental: A1n=8 Participants	2.20	1.21
Placebo Comparator: A2n=8 Participants	2.56	1.41

Secondary/protocol endpoint/low confidence

Pain Assessment in Advanced Dementia (PAINAD)

Time frame:6 weeks

descriptive

Secondary/registry result/low confidence

Pain Assessment in Advanced Dementia (PAINAD)

Time frame:6 weeks

descriptive

Posted result

Group	Value (mean), units on a scale	Standard deviation
Phase B: Open Labeln=8 Participants	1.93	1.98

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.