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

Sponsored by:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00385684

Purpose

The purpose of this study is 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 is also known as Lortab and contains both a narcotic pain medication and the same pain medication as contained in Tylenol. The study will also assess how well patients tolerate this medication and will measure the impact that relief of discomfort has on agitation and other symptoms. This study is an eight-week long clinical trial for discomfort among veterans with advanced dementia who are admitted to a Nursing Home Care Unit (NHCU) at the Tuscaloosa VA Medical Center.

Condition	Intervention	Phase
Alzheimer Disease Dementia Dementia, Vascular Pain	Drug: Lortab	Phase IV

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dementia

Drug Information available for: Vicodin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Low-Dose Opiate Therapy for Discomfort in Dementia (L-DOT)

Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment:	48
Study Start Date:	October 2006
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1	Drug: Lortab

Detailed Description:

OBJECTIVES: The primary objective of the Low-Dose Opiate Therapy for Discomfort in Dementia (L-DOT) project will be to determine whether low-dose opiates are effective and well tolerated for the treatment of pain (as manifest by discomfort) in patients with advanced dementia. The secondary objectives will be to assess the tolerability of such treatment and to assess the impact of effective analgesia on agitation and other symptom burden in this population.

RESEARCH DESIGN: This study is a two-week double-blind, double-dummy, placebo-controlled, crossover trial of low-dose hydrocodone/acetaminophen (Lortab) for discomfort among veterans with a dementia, followed by six weeks of open-label therapy for patients who tolerate treatment during the first two weeks (eight weeks total treatment on study).

METHODOLOGY: After consent, patients over age 55 with dementia residing in a nursing home care unit at Tuscaloosa VAMC who demonstrate significant discomfort (as measured by the Pain Assessment in Advanced Dementia - PAINAD) will be randomized to one of two groups, using a double-blind, double-dummy, placebo-controlled, crossover design. Patients will be randomly assigned to treatment with either hydrocodone/acetaminophen 2.5mg/250mg TID scheduled with placebo TID PRN or placebo TID scheduled with hydrocodone/acetaminophen 2.5mg/250mg TID PRN. After one week's treatment, patients will be crossed over to the other (opposite) regimen, for a total of two weeks of blinded treatment. Patients who tolerate treatment with hydrocodone/acetaminophen will be eligible for a six-week, open-label continuation phase. Outcome measures will include pain/discomfort, agitation, symptom burden, tolerability/adverse effects, and dropout rates. Preliminary sample size calculations indicate that 42 patients (48 patients accounting for dropouts) would need to be enrolled over three years to detect a difference between treatments with power of .80 and two-tailed alpha of .05.

SIGNIFICANCE: There is evidence that pain is both underrecognized and undertreated in long term care settings. This study will make a significant contribution to the evidence base for a common and problematic situation among veterans with advanced dementia. Advances in pain and symptom control are central to the improvement of palliative care intervention for dementia patients. Low-dose opiates are the logical next category of analgesics to consider, but have not been studied for this purpose in this population.

Eligibility

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00385684

Locations

United States, Alabama
VA Medical Center, Tuscaloosa
Tuscaloosa, Alabama, United States, 35404

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Principal Investigator:

A. Lynn Snow, PhD MS BS

VA Medical Center, Tuscaloosa

More Information

Responsible Party:	Department of Veterans Affairs ( Snow, A. - Principal Investigator )
Study ID Numbers:	F4483I
Study First Received:	October 6, 2006
Last Updated:	August 18, 2008
ClinicalTrials.gov Identifier:	NCT00385684
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

Agitation
Alzheimer Disease
Analgesics
Dementia
Narcotics

Opioid
Pain
Palliative Care
Psychomotor
Suffering, Physical

Study placed in the following topic categories:

Arterial Occlusive Diseases
Alzheimer Disease
Vascular Diseases
Central Nervous System Diseases
Psychomotor Agitation
Pain
Arteriosclerosis
Brain Diseases
Neurodegenerative Diseases

Intracranial Arterial Diseases
Cerebrovascular Disorders
Cognition Disorders
Intracranial Arteriosclerosis
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dementia, Vascular
Dementia
Delirium

Additional relevant MeSH terms:

Nervous System Diseases
Cardiovascular Diseases
Tauopathies

ClinicalTrials.gov processed this record on January 16, 2009