L‐DOT study.

Trial name or title	Low‐Dose Opiate Therapy for Discomfort in Dementia (L‐DOT)
Methods	Double blind, double dummy, placebo controlled cross‐over RCT
Participants	Patients over age 55 y 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 PAINAD). Participants will be at an advanced stage of dementia demonstrated by a score of 6 or greater on the Functional Assessment Staging (FAST) scale and are unable to report pain in a reliable and consistent manner
Interventions	Arm 1. During the one‐week experimental phase, the participants will receive hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid three times daily (TID), with liquid placebo available as needed (PRN) Arm 2. During the one‐week experimental phase, the participants will receive a liquid placebo TID with hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid available PRN Arm 3. During the 6‐week open‐label phase, those who tolerate hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid three times daily (TID) during the double blind phase of the trial will enter a six‐week, open‐label extension phase of the study, receiving either hydrocodone/acetaminophen at the same dose or the most appropriate formulary alternative (for those who are judged to be responders during the double blind phase) or a higher dose (hydrocodone/acetaminophen 5/500 mg TID or the most appropriate formulary alternative). Participant can also receive up to 2 PRN at the same dose as listed above, but not to exceed 2.5 g of acetaminophen
Outcomes	Discomfort Battery (DB), Discomfort Scale for patient with Dementia Alzheimer's Type (DS‐DAT) after 8 weeks
Starting date	October 2007
Contact information	A Lynn Snow, PhD MS BS, VA Medical Center, Tuscaloosa
Notes	Active, not recruiting