CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 93 enrolled
Drug / intervention
Lorazepam +3 moredrug
Likely dose
Lorazepam 3 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01949662
NCT01949662Phase 2Active

A Preliminary Double-Blind Randomized Controlled Trial of Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer Admitted to a Palliative Care Unit

M.D. Anderson Cancer Center·interventional·Posted Sep 24, 2013·Updated Feb 13, 2026

In Brief

A Phase 2 clinical trial evaluating Lorazepam, Placebo, and 2 other interventions for Advanced Cancers. Active but no longer recruiting, targeting 93 participants across 1 site.

Detailed Summary

This randomized phase II trial studies how well haloperidol with or without lorazepam works in reducing confusion, disorientation, and inability to think or remember clearly (delirium) in patients with cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Palliative therapy with haloperidol and lorazepam may reduce symptoms of delirium and help patients with advanced cancer live more comfortably. It is not yet known whether lorazepam may be an effective treatment for delirium when given with haloperidol.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2Active
201420152016201720182019202020212022202320242025202620272028
First PostedSep 24, 2013
Enrollment StartJan 1, 2014
Primary CompletionAug 26, 2016
Study CompletionJan 1, 2028
TodayJul 1, 2026
Enrollment to primary: 2.7 yearsPosted 12.8 years ago

Interventions

Lorazepamdrug

3 mg by vein one time only.

Placebodrug

Placebo consisting of preservative free 0.9% normal saline given one time by vein.

Haloperidol decanoatedrug

8 mg/day by vein.

Questionnairesbehavioral

Questionnaire completion at baseline, and every day while participant is in the palliative care unit. These questions will take about 20 minutes to complete.