CompletedPhase 1

Behavioral Pharmacology of Cannabis in Older Adults

United States3 participantsStarted 2025-05-01

Plain-language summary

This study examines the effects of cannabis on mood, cognitive and psychomotor performance, balance and vital signs in older adults.

Who can participate

Age range

55 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Self-reported history of marijuana use with no serious adverse effects * Negative urine toxicology screen for psychoactive drugs (cocaine, fentanyl, methadone, opiates, buprenorphine, methamphetamine, amphetamines, barbiturates, oxycodone, benzodiazepines, phencyclidine, and THC) and CBD * Negative breath alcohol concentration * Report ≥1 year abstinence from nicotine and tobacco * Report ≥1 month of abstinence from THC- and CBD- containing products and be willing to abstain from these products for the study duration * Blood pressure (BP) reading ≤140/90 and ≥110/70 at the time of screening * Read and understand English (because assessments are validated in English) * Menopause as defined as no reported menstruation for ≥12 months (females only) * Negative urine pregnancy test (females only) * Stable medical conditions controlled by non-psychoactive medications that do not alter THC/CBD metabolism (e.g., hypertension under control with certain antihypertensives; type II diabetes controlled by metformin) Exclusion Criteria: * A history of moderate to severe substance use disorders (SUDs) (except tobacco), according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), and no recent history (≥1 year) of SUD * Current tobacco/nicotine use * ECG abnormalities at screening including but not limited to: bradycardia (\<55 beats per minute); prolonged QTc interval (\>450 msec); Wolff-Parkinson White syndrome; wide complex tachycar…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Vital Signs - Blood Pressure

Timeframe: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration

Vital Signs - Respiration

Timeframe: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration

Vital Signs - Pulse

Timeframe: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration

Self/Observer Ratings - Pain

Timeframe: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration

Self/Observer Ratings - Side Effects

Timeframe: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration

Self/Observer Ratings - POMS

Timeframe: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration

Self/Observer Ratings - CADSS

Timeframe: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration

Trial details

NCT IDNCT06055309

SponsorUniversity of Arkansas

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Health Services for the Aged trials

Who can participate

Age range

55 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Vital Signs - Blood Pressure

Timeframe: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration

Vital Signs - Respiration

Timeframe: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration

Vital Signs - Pulse

Timeframe: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration

Self/Observer Ratings - Pain

Timeframe: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration

Self/Observer Ratings - Side Effects

Timeframe: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration

Self/Observer Ratings - POMS

Timeframe: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration

Self/Observer Ratings - CADSS

Timeframe: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration