What side effects are associated with this type of intervention?

The most common treatments for psychomotor agitation, particularly those similar to dronabinol (a synthetic cannabinoid agonist), include synthetic cannabinoids and other medications like haloperidol. Known side effects of synthetic cannabinoids include dizziness, sedation, confusion, dissociation, and a 'high' feeling. Haloperidol, another treatment for agitation, can cause side effects such as decreased aggression but does not significantly improve other aspects of agitation. Both treatments can have significant adverse effects, and patient preference often favors cannabinoids despite these issues.

What prior FDA approvals exist?

The FDA has approved several treatments for psychomotor agitation, though specific approvals for synthetic cannabinoid agonists like dronabinol are less common. Dronabinol itself is being studied for agitation in dementia, showing some promise in clinical trials. Other treatments for agitation often involve benzodiazepines, such as lorazepam and midazolam, which are used for their sedative effects. These drugs are typically employed in acute settings to manage severe agitation and related symptoms.

What other types of research exist?

Promising alternatives to Dronabinol for treating psychomotor agitation in 2024 include HU-210, (R)-methanandamide, and benzodiazepines for anxiety-related agitation. Nonpharmacologic options like acupuncture may also be considered, though their efficacy is modest.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (0 weeks) to 18 weeks

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

0 / 10Eligibility criteria met

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.