Dronabinol for Agitation in Dementia

Palo Alto (17 mi)

Overseen byJacobo E Mintzer, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Ralph H. Johnson VA Medical Center

No Placebo Group

Prior Safety Data

Approved in 6 jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

I often feel very agitated or irritable.

I have been diagnosed with agitation related to dementia.

I can make my own medical decisions or have someone legally able to do so for me.

I have someone who can be with me for at least 10 hours a week.

I have been diagnosed with a type of dementia.

I can swallow pills without difficulty.

Exclusion Criteria

I have had psychotic symptoms from a mental health condition other than dementia in the last 2 years.

I have not used cannabinoids or illicit drugs in the last 3 months.

I do not have an unstable psychiatric or neurological condition.

I am not allergic to cannabinoids or sesame oil.

Treatment Details

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.

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.

Dronabinol is already approved in United States, United States, Australia, Canada for the following indications:

🇺🇸 Approved in United States as Marinol for: