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

NCT00385684 | Completed Phase 4 Results DMC

• 1 other identifier: F4483-I
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 3

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 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.

Conditions

Alzheimer Disease; Dementia; Dementia, Vascular; Pain

Keywords

Agitation; Alzheimer Disease; Analgesics; Dementia; Narcotics; Opioid; Pain; Palliative Care; Psychomotor; Suffering, Physical

Outcome Measures

Primary Outcomes (1)

• Pain Assessment in Advanced Dementia (PAINAD)

  Pain intensity observational assessment for persons with severe dementia. Higher scores indicate more pain/discomfort. Scale range is 0-10.

  Two (2) weeks

Secondary Outcomes (1)

• Pain Assessment in Advanced Dementia (PAINAD)

  6 weeks

Study Arms (3)

A1: hydrocodone/APAP w placebo PRN

EXPERIMENTAL

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.

Drug: hydrocodone/APAP w placebo PRN

A2: placebo w hydrocodone/APAP PRN

PLACEBO COMPARATOR

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.

Drug: placebo with hydrocodone/APAP PRN

B: Open label hydrocodone/acetaminophen

ACTIVE COMPARATOR

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.

Drug: hydrocodone/APAP

Interventions

hydrocodone/APAP w placebo PRN DRUG

Hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid three times daily (TID). With liquid placebo available PRN.

Also known as: Lortab

A1: hydrocodone/APAP w placebo PRN

hydrocodone/APAP DRUG

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.

Also known as: Lortab

B: Open label hydrocodone/acetaminophen

placebo with hydrocodone/APAP PRN DRUG

Liquid placebo PRN. Also available PRN is Hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid.

Also known as: placebo with Lortab PRN

A2: placebo w hydrocodone/APAP PRN

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

Tuscaloosa VA Medical Center

Tuscaloosa, Alabama, 35404, United States

Location

Tuscaloosa Veterans Affairs Medical Center

Tuscaloosa, Alabama, 35404, United States

Location

VA Medical Center, Tuscaloosa

Tuscaloosa, Alabama, 35404, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Dementia, Vascular; Pain; Psychomotor Agitation

Interventions

oxycodone-acetaminophen

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyskinesias; Psychomotor Disorders; Neurobehavioral Manifestations; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Andrea L. Snow
• Organization: Tuscaloosa VA Medical Center

lynn.snow@va.gov

205-554-2000

Study Officials

• Andrea Snow, PhD MS BS

  VA Medical Center, Tuscaloosa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2006
• First Posted: October 11, 2006
• Study Start: October 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: June 1, 2014
• Last Updated: November 20, 2015
• Results First Posted: November 20, 2015

Record last verified: 2015-11

Locations

US (3)