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Cannabinoid

Dronabinol for Agitation in Dementia

Phase 2
Waitlist Available
Led By Jacobo E Mintzer, MD
Research Sponsored by Ralph H. Johnson VA Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of clinically significant agitation and/or irritability with an NPI subscale score greater than or equal to 4
Must meet International Psychogeriatric Association's provisional definition of agitation in dementia
Must not have
History of psychotic symptoms due to another psychiatric illness other than dementia in the past 2 years
Use of cannabinoids (including over the counter products such as 'CBD' or medical cannabis) or other illicit drugs in the past 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (0 weeks) to 18 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing dronabinol, a cannabis-based medication, to see if it can reduce agitation in US Veterans with moderate to severe dementia. The study will evaluate the effectiveness of dronabinol and monitor for any side effects. All participants will eventually receive dronabinol during the study. Dronabinol is a synthetic THC that has been previously tested for treating neuropsychiatric symptoms in dementia, showing potential benefits for agitation and behavioral disturbances.

Who is the study for?
This trial is for US Veterans with moderate to severe dementia experiencing significant agitation. Participants must have a stable medication regimen, be able to swallow capsules, and not use cannabinoids or illicit drugs recently. They need a study partner who spends at least 10 hours per week with them and cannot have unstable psychiatric disorders or medical conditions.
What is being tested?
The trial tests the effectiveness of dronabinol in treating agitation in dementia patients compared to a placebo. Each participant will receive both treatments over two phases (8 weeks each) separated by a washout period, ensuring everyone gets dronabinol at some point.
What are the potential side effects?
Potential side effects of dronabinol may include mood changes, dizziness, sleepiness, confusion, hallucinations or worsening of pre-existing heart conditions due to its psychoactive properties.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I often feel very agitated or irritable.
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I have been diagnosed with agitation related to dementia.
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I can make my own medical decisions or have someone legally able to do so for me.
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I have someone who can be with me for at least 10 hours a week.
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I have been diagnosed with a type of dementia.
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I can swallow pills without difficulty.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had psychotic symptoms from a mental health condition other than dementia in the last 2 years.
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I have not used cannabinoids or illicit drugs in the last 3 months.
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I do not have an unstable psychiatric or neurological condition.
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I am not allergic to cannabinoids or sesame oil.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in agitation, Cohen Mansfield Agitation Inventory (CMAI)
Safety and tolerability, Treatment Emergent Adverse Events
Secondary study objectives
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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Dronabinol, a synthetic cannabinoid agonist, reduces psychomotor agitation by interacting with CB1 receptors in the brain, which helps modulate neurotransmitter release and stabilize neural activity. This is similar to how benzodiazepines enhance the effect of GABA to produce sedative and anxiolytic effects. Understanding these mechanisms is important for selecting the most appropriate treatment, leading to more effective and targeted management of agitation symptoms.
Effects of delta-9-tetrahydrocannabinol on social behaviour in the laboratory mouse and rat.Analysis and pharmacotoxicity of feruloyltyramine as a new constituent and p-coumaroyltyramine in Cannabis sativa L.Extrapyramidal effects of methanandamide, an analog of anandamide, the endogenous CB1 receptor ligand.

Find a Location

Who is running the clinical trial?

Ralph H. Johnson VA Medical CenterLead Sponsor
19 Previous Clinical Trials
5,460 Total Patients Enrolled
JHSPH Center for Clinical TrialsOTHER
12 Previous Clinical Trials
10,520 Total Patients Enrolled
2 Trials studying Psychomotor Agitation
373 Patients Enrolled for Psychomotor Agitation
Jacobo E Mintzer, MDPrincipal InvestigatorRalph 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
~0 spots leftby Nov 2025