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Antipsychotic

Haloperidol + Lorazepam for Delirium in Advanced Cancer

Phase 2

Waitlist Available

Led By David Hui, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 30 minutes

Awards & highlights

Study Summary

This trial is testing how well haloperidol with or without lorazepam works to reduce delirium symptoms in patients with cancer that has spread and usually can't be cured or controlled.

Who is the study for?

This trial is for adults with advanced cancer experiencing delirium, who are in a palliative care unit and have had hyperactive or mixed symptoms recently. They must be on low-dose haloperidol and not have conditions like myasthenia gravis, glaucoma, Parkinson's disease, dementia, uncontrolled seizures, or certain heart issues.Check my eligibility

What is being tested?

The study is testing if adding lorazepam to haloperidol can better reduce delirium symptoms in patients with advanced cancer compared to using just haloperidol. Participants will be randomly assigned to receive either both drugs or only haloperidol alongside a placebo.See study design

What are the potential side effects?

Haloperidol may cause movement disorders or mood changes while Lorazepam could lead to drowsiness or memory problems. Both drugs might also contribute to an increased risk of falls due to muscle weakness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 30 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 30 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 30 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Absolute Richmond Agitation-Sedation Scale Score at 8 Hour, Points

Change in Richmond Agitation-Sedation Scale Score (Baseline to 8 hr), Points

Secondary outcome measures

Change in Richmond Agitation-Sedation Scale Score From Baseline to 30 Min

Number of Participants With Richmond Agitation-Sedation Scale Score >=1 Within 8 hr

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Lorazepam + HaloperidolExperimental Treatment3 Interventions

Participants given a single dose of lorazepam 3 mg by vein, in addition to a standardized dose of haloperidol 8 mg/day by vein, while in palliative care unit. Questionnaire completion at baseline, and every day while participant is in the palliative care unit. These questions will take about 20 minutes to complete

Group II: Placebo + HaloperidolActive Control3 Interventions

Participants receive placebo, preservative free 0.9% normal saline, by vein plus a standardized dose of haloperidol 8 mg/day by vein, while in palliative care unit. Questionnaire completion at baseline, and every day while participant is in the palliative care unit. These questions will take about 20 minutes to complete

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lorazepam

FDA approved

Questionnaires

2013

Completed Phase 2

~3330

Haloperidol

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,688 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,060 Total Patients Enrolled

David Hui, MDPrincipal InvestigatorM.D. Anderson Cancer Center

16 Previous Clinical Trials

101,447 Total Patients Enrolled

Media Library

Haloperidol (Antipsychotic) Clinical Trial Eligibility Overview. Trial Name: NCT01949662 — Phase 2

Cancer Research Study Groups: Lorazepam + Haloperidol, Placebo + Haloperidol

Cancer Clinical Trial 2023: Haloperidol Highlights & Side Effects. Trial Name: NCT01949662 — Phase 2

Haloperidol (Antipsychotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01949662 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we still able to enroll people in this experiment?

"No, according to the clinicaltrials.gov website, this study is not actively recruiting patients at this time. The trial was originally posted on 1/1/2014 and was most recently updated on 8/30/2022. 2728 other trials are actively recruiting participants right now."

Answered by AI

Are Lorazepam and Haloperidol often tested together in clinical trials?

"There are a total of 13 separate clinical trials testing the efficacy of Lorazepam + Haloperidol. Of those, 3 are still actively recruiting patients. Although most of the research is being conducted in Saint Joseph, Michigan, there are 55 different locations across the United States where you can participate in this study."

Answered by AI

What conditions are Lorazepam + Haloperidol commonly prescribed for?

"This medication, which is a combination of lorazepam and haloperidol, is most often used to manage schizophrenia. However, it can also be taken as treatment for other conditions such as phencyclidine or insomnia in palliative care settings."

Answered by AI

Are there any well-documented dangers associated with taking Lorazepam and Haloperidol together?

"Given that this is a phase 2 trial and there is some evidence of safety but none for efficacy, our team has given Lorazepam + Haloperidol a score of 2."

Answered by AI

How many people are willing to try this new treatment option?

"Unfortunately, this particular clinical trial is no longer actively recruiting patients. The trial was initially posted on 1/1/2014 and the last edit was on 8/30/2022. However, there are presently 2715 studies actively recruiting participants with cancer and 13 studies for Lorazepam + Haloperidol that are admitting patients."

Answered by AI

Recent research and studies

JamaJournal

Effect of Lorazepam with Haloperidol Vs Haloperidol Alone on Agitated Delirium in Patients with Advanced Cancer Receiving Palliative Care

Hui, David, Susan Frisbee-Hume, Annie Wilson, Seyedeh S. Dibaj, Thuc Nguyen, Maxine De La Cruz, Paul Walker, et al.. 2017. “Effect of Lorazepam with Haloperidol Vs Haloperidol Alone on Agitated Delirium in Patients with Advanced Cancer Receiving Palliative Care”. Jama. American Medical Association (AMA). doi:10.1001/jama.2017.11468.

clinicaltrials.govStudy

Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer

2014. "Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01949662.