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

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ClinicalTrials.gov Identifier: NCT00385684
Recruitment Status : Completed
First Posted : October 11, 2006
Results First Posted : November 20, 2015
Last Update Posted : November 20, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Alzheimer Disease
Dementia
Dementia, Vascular
Pain
Interventions Drug: hydrocodone/APAP w placebo PRN
Drug: hydrocodone/APAP
Drug: placebo with hydrocodone/APAP PRN
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title A1 and Then A2 Then Phase B A2 THEN A1 Then Phase B
Hide Arm/Group Description

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.

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.

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.

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.

Period Title: FIRST INTERVENTION OF PHASE A
Started 6 5
Completed 5 5
Not Completed 1 0
Reason Not Completed
Death             1             0
Period Title: SECOND INTERVENTION OF PHASE A
Started 5 5
Completed 5 3
Not Completed 0 2
Reason Not Completed
Adverse Event             0             1
study drug recall             0             1
Period Title: PHASE B
Started 5 3
Completed 5 3
Not Completed 0 0
Arm/Group Title ALL STUDY PARTICIPANTS
Hide Arm/Group Description

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.

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.

Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
Veterans with severe dementia residing in VA nursing home.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
0
   0.0%
Between 18 and 65 years
0
   0.0%
>=65 years
11
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
0
   0.0%
Male
11
 100.0%
1.Primary Outcome
Title Pain Assessment in Advanced Dementia (PAINAD)
Hide Description Pain intensity observational assessment for persons with severe dementia. Higher scores indicate more pain/discomfort. Scale range is 0-10.
Time Frame Two (2) weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental: A1 Placebo Comparator: A2
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.20  (1.21) 2.56  (1.41)
2.Secondary Outcome
Title Pain Assessment in Advanced Dementia (PAINAD)
Hide Description Pain intensity observational assessment for persons with severe dementia. Higher scores indicate more pain/discomfort.
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase B: Open Label
Hide Arm/Group Description:
Those participants for whom the study medication was tolerated during Phase A (i.e., the closed label, double-blind phase of the trial) entered a six-week open-label phase.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.93  (1.98)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ALL STUDY PARTICIPANTS
Hide Arm/Group Description

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.

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.

All-Cause Mortality
ALL STUDY PARTICIPANTS
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
ALL STUDY PARTICIPANTS
Affected / at Risk (%) # Events
Total   2/11 (18.18%)    
Blood and lymphatic system disorders   
Death  [1]  1/11 (9.09%)  1
Respiratory, thoracic and mediastinal disorders   
Respiratory Distress  [2]  1/11 (9.09%)  1
Indicates events were collected by systematic assessment
[1]
Sepsis. Not related to study drug/procedures. This participant was in late stages of dementia, at end of life.
[2]
Determined 'related to study drug/procedures' because respiratory distress is a known side effect of the study drug. Participant thus exited from study. This participant was in late stages of dementia.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ALL STUDY PARTICIPANTS
Affected / at Risk (%) # Events
Total   1/11 (9.09%)    
Respiratory, thoracic and mediastinal disorders   
Serum C02 level dropped  [1]  1/11 (9.09%)  1
Indicates events were collected by systematic assessment
[1]
At regularly scheduled laboratory blood draw, serum C02 level was dropped. Administration of study medication was halted while subject evaluated. C02 level re-evaluated by 2 follow-up lab tests and review by attending physician.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Andrea L. Snow
Organization: Tuscaloosa VA Medical Center
Phone: 205-554-2000 ext 2260
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00385684     History of Changes
Other Study ID Numbers: F4483-I
First Submitted: October 6, 2006
First Posted: October 11, 2006
Results First Submitted: June 2, 2014
Results First Posted: November 20, 2015
Last Update Posted: November 20, 2015