- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00385684
Low-Dose Opiate Therapy for Discomfort in Dementia (L-DOT) (LDOT)
Study Overview
Status
Conditions
Intervention / Treatment
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 of pain (as manifest by discomfort) in patients with advanced dementia.
RESEARCH DESIGN: This study was 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 tolerated 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 (or at home who receive care) at Tuscaloosa VAMC who demonstrate significant discomfort (as measured by the Pain Assessment in Advanced Dementia - PAINAD) were randomized to one of two groups, using a double-blind, double-dummy, placebo-controlled, crossover design. Patients were randomly assigned to treatment with either hydrocodone/acetaminophen 2.5mg/250mg q8hrs scheduled with placebo q8hrs PRN or placebo q8hrs scheduled with hydrocodone/acetaminophen 2.5mg/250mg q8hrs PRN. After one week's treatment, patients were crossed over to the other (opposite) regimen, for a total of two weeks of blinded treatment. Patients who tolerated treatment with hydrocodone/acetaminophen were eligible for a six-week, open-label continuation phase. The primary outcome measure was pain/discomfort. Preliminary sample size calculations indicated that 42 patients (48 patients accounting for dropouts) would be needed 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 under recognized and undertreated in long term care settings. This study hoped to 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 been rarely studied for this purpose in this population.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Alabama
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Tuscaloosa, Alabama, United States, 35404
- Tuscaloosa VA Medical Center
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Tuscaloosa, Alabama, United States, 35404
- VA Medical Center, Tuscaloosa
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Tuscaloosa, Alabama, United States, 35404
- Tuscaloosa Veterans Affairs Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A1: hydrocodone/APAP w placebo PRN
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.
|
Hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid three times daily (TID).
With liquid placebo available PRN.
Other Names:
|
Placebo Comparator: A2: placebo w hydrocodone/APAP 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.
|
Liquid placebo PRN.
Also available PRN is Hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid.
Other Names:
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Active Comparator: B: Open label hydrocodone/acetaminophen
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.
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Participants judged as responders during Phase A continue the same dose of study medication (hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid TID).
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Assessment in Advanced Dementia (PAINAD)
Time Frame: Two (2) weeks
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Pain intensity observational assessment for persons with severe dementia.
Higher scores indicate more pain/discomfort.
Scale range is 0-10.
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Two (2) weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Assessment in Advanced Dementia (PAINAD)
Time Frame: 6 weeks
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Pain intensity observational assessment for persons with severe dementia.
Higher scores indicate more pain/discomfort.
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6 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Andrea Snow, PhD MS BS, VA Medical Center, Tuscaloosa
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Tauopathies
- Intracranial Arterial Diseases
- Intracranial Arteriosclerosis
- Leukoencephalopathies
- Dementia
- Alzheimer Disease
- Dementia, Vascular
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antipyretics
- Analgesics, Opioid
- Narcotics
- Respiratory System Agents
- Antitussive Agents
- Acetaminophen
- Hydrocodone
- Acetaminophen, hydrocodone drug combination
Other Study ID Numbers
- F4483-I
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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