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Dronabinol First for Psychomotor Agitation

Ralph H. Johnson VA Health Care System, Charleston, SC
Targeting 4 different conditionsDronabinolPhase 2Waitlist AvailableLed by Jacobo E Mintzer, MDResearch Sponsored by Ralph H. Johnson VA Medical Center

Study Summary

This trial investigates the effects of dronabinol on agitation in Veterans with moderate to severe dementia. Subjects will receive dronabinol or placebo & be evaluated for changes in agitation, cognition & physical health.

Eligible Conditions
  • Psychomotor Agitation
  • Dementia Severe
  • Moderate Dementia
  • Behavioral Symptoms

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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You have been diagnosed with a severe memory and thinking problem called dementia.
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You show signs of being very agitated or easily irritated, with a score of 4 or higher on a specific test.
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You have a FAST score of 5 or higher, which means you have significant difficulties with daily activities.
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You must show signs of restlessness or irritability caused by dementia, as defined by the International Psychogeriatric Association.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow ups ~ baseline (0 weeks) to 18 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (0 weeks) to 18 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in agitation, Cohen Mansfield Agitation Inventory (CMAI)
Safety and tolerability, Treatment Emergent Adverse Events
Secondary outcome measures
Change in QTc interval on Electrocardiogram (EKG)
Change in agitation, Neuropsychiatric Inventory (NPI)
Change in blood pressure
+9 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Placebo FirstExperimental Treatment1 Intervention
Participants will take matching placebo capsules twice daily for 8 weeks, followed by a three week washout period. They will then begin taking dronabinol 2.5 mg capsules twice daily for 1 week, followed by dronabinol 5 mg twice daily for 6 weeks, followed by dronabinol 2.5 mg twice daily for 1 week.
Group II: Dronabinol FirstExperimental Treatment1 Intervention
Participants will take Dronabinol 2.5 mg capsules twice daily for 1 week, followed by dronabinol 5 mg twice daily for 6 weeks, followed by dronabinol 2.5 mg twice daily for 1 week. They will then undergo a 3-week washout period, followed by placebo capsules twice daily for 8 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dronabinol
2003
Completed Phase 4
~2080

Find a site

Who is running the clinical trial?

Ralph H. Johnson VA Medical CenterLead Sponsor
18 Previous Clinical Trials
5,538 Total Patients Enrolled
JHSPH Center for Clinical TrialsOTHER
10 Previous Clinical Trials
3,337 Total Patients Enrolled
2 Trials studying Psychomotor Agitation
578 Patients Enrolled for Psychomotor Agitation
Jacobo E Mintzer, MDPrincipal Investigator
Ralph H. Johnson VA Healthcare System
Jessica E Broadway, MDPrincipal Investigator
Ralph H. Johnson VA Healthcare System

Media Library

Dronabinol (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT05612711 — Phase 2
Psychomotor Agitation Research Study Groups: Dronabinol First, Placebo First
Psychomotor Agitation Clinical Trial 2023: Dronabinol Highlights & Side Effects. Trial Name: NCT05612711 — Phase 2
Dronabinol (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05612711 — Phase 2

Frequently Asked Questions

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

What are the objectives of this experiment?

"The primary intention of this trial, monitored for 18 weeks from the Baseline stage (0 Weeks), is to measure agitation levels using Cohen Mansfield Agitation Inventory (CMAI). Also being measured are pain with Pain Assessment in Advanced AD (PAIN-AD) scale which scores between 0 and 10; cognition via Alzheimer's Disease Assessment Scale - Cognitive Section (ADAS-Cog) whose values range from 0 to 70; and nutritional status through prealbumin concentrations ranging in milligrams per decilitre."

Answered by AI

Are there currently any openings in this trial for participants?

"Confirming the information that is available on clinicaltrials.gov, this trial has ended its recruitment phase and is no longer enrolling patients. It was initially posted in November 1st 2023 and last updated on November 4th 2022; however, there are a multitude of other studies actively seeking participants which total 806 at the moment."

Answered by AI

What perils could one encounter when using Dronabinol First?

"Dronabinol First was assigned a safety score of 2 due to the existence of Phase 2 trial data demonstrating its relative security, but no evidence yet exists supporting its efficacy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Dronabinol for Agitation in Dementia Crossover Trial
Jacobo Mintzer, MD 2023. "Dronabinol for Agitation in Dementia Crossover Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05612711.
~33 spots leftby Nov 2025
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