Health Services for the AgedPhase 1NCT06055309
Behavioral Pharmacology of Cannabis in Older Adults
A Phase 1 study testing Cannabis (up to three doses) in people with Health Services for the Aged, run by University of Arkansas at 1 site in United States.
Trial summary
This study examines the effects of cannabis on mood, cognitive and psychomotor performance, balance and vital signs in older adults. Read more about this study
- Who is it for?
- Ages 55 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Services for the Aged
- What is being tested?
- Cannabis (up to three doses)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 31 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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 tachycardia; 2nd degree, Mobitz type II heart block; 3rd degree heart block; left or right bundle branch block; pre-existing severe gastrointestinal narrowing (pathologic or iatrogenic)
- Have a serious and uncontrolled medical condition (major cardiovascular, renal, endocrine, or hepatic disorder) including a history of serious head trauma or neurological disorder (e.g., seizure disorder)
- Meet Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for lifetime psychosis, schizophrenia, or bipolar disorder or current major depressive disorder, suicidality (e.g., last month suicidal ideation or suicide attempt in past year, as measured by Columbia Suicide Severity Rating Scale) or have significant psychiatric symptoms of another disorder
- Diagnosis of a cognitive disorder (Alzheimer's Disease, dementia) or a score of <25 on the Montreal Cognitive Assessment (MoCA) for Dementia during screening
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- Currently taking any prescribed medication for a psychiatric disorder
- Current use of over-the-counter medication or prescription psychoactive drugs that would be expected to have major interaction with THC (e.g., warfarin, serotonin reuptake inhibitors, tricyclic antidepressants, sildenafil).
- Reported cancer-related fibromyalgia or neuropathic pain conditions
- Have a medical contraindication to, or prior serious adverse events from, cannabis or brownie ingredients (e.g., food sensitivities to gluten/wheat, chocolate, eggs)
- Consume the equivalent of >2 cups of coffee/day (to reduce variability related to metabolic interactions with caffeine)
- Have any of the following: uncontrolled hypertension (i.e., systolic >140 mm Hg and/or diastolic >90 mm Hg on three separate occasions; systolic >170 or diastolic >110 on any occasion), liver function tests >3 times normal, blood urea Nitrogen and Creatinine outside normal range
- Have a physical limitation that will interfere with completing study tasks
- Have child-bearing potential (women)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Science
Little Rock, Arkansas, 72205
About this study
Official title: Behavioral Pharmacology of Cannabis in Older Adults: A Pilot Study
This study examines the effects of cannabis on mood, cognitive and psychomotor performance, balance and vital signs in older adults.
Read the detailed description
The overarching aims of this pilot study are to determine the dose-related effects of cannabis and explore feasibility and acceptability of conducting a rigorous behavioral pharmacology study in this population. Using a within-subject design in older adults (55-70 years), this study will (1) determine acute dose-related effects of cannabis on physiological, subjective, cognitive, and psychomotor measures and (2) explore acceptability/feasibility of this approach among older adults in order to refine procedures for future studies. Volunteers (55-70 years) will undergo three 7.5-hour experimental sessions conducted one week apart, in which they receive cannabis containing various oral doses of tetrahydrocannabinol (THC) / cannabidiol (CBD) administered in a brownie formulation and the following are assessed: 1) self-reported and/or observer ratings of positive and negative subjective effects; 2) performance effects, measured by reaction time, coordination, and cognitive impairment; and 3) cardiovascular effects. Participants will be contacted the day after each session for feedback on the acceptability of session length, types, number and duration of tasks and any adverse events. Reasons for dropout will also be sought to determine whether study procedures impacted attrition. Findings will: 1) provide investigative team with the hands-on research cannabis research experience; 2) elucidate the optimal THC dose range; and 3) determine the most feasible/acceptable study design in older adults that will inform further rigorous studies examining acute and chronic administration of cannabis formulations among older adults.
- Conditions
- Health Services for the Aged
- Being tested
- Cannabis (up to three doses)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabis (up to three doses)Drug
a dose of cannabis will be baked into brownies
| Study group | Role | What they receive |
|---|---|---|
| Cannabis (up to three doses) | Experimental | Brownies containing a dose of cannabis Receives: Drug: Cannabis (up to three doses) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital Signs - Blood Pressure
systolic/diastolic blood pressure (mmHg)
Measured: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration
Vital Signs - Respiration
respiration rate (breaths per minute)
Measured: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration
Vital Signs - Pulse
pulse (beats per minute)
Measured: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration
Self/Observer Ratings - Pain
Visual Analog Scales (making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain")
Measured: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration
Self/Observer Ratings - Side Effects
Side Effects Ratings
Measured: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration
Self/Observer Ratings - POMS
Profile of Mood States (POMS) short form - using a five-point scale ranging from "not at all" to "extremely."
Measured: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration
Self/Observer Ratings - CADSS
Clinician Administered Dissociative Symptoms Scale (CADSS)-
Measured: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration
Self/Observer Ratings - PROMIS
Patient Reported Outcomes Measurements Information System (PROMIS) Cognitive Function short form v2
Measured: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration
Balance Tests - Four-Stage
The Four-Stage Balance Test- When the patient is steady, let go, and time how long they can maintain the position, but remain ready to assist the patient if they should lose their balance.
Measured: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration
Balance Tests - Timed Up and Go
The Timed Up \& Go Test- Timing commences on the command 'go' and stops when the subject's back is positioned against the back of the chair after sitting down.
Measured: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration
Balance Tests - 30 sec chair-stand
The 30-Second Chair-Stand Test- the number of times the patient comes to a full standing position in 30 seconds.
Measured: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration
Secondary outcomes (9)
Cognitive Function Tests - Flanker
Flanker inhibitory control and attention test- participants are required to indicate the left-right orientation of a centrally presented stimulus while inhibiting attention to the potentially incongruent stimuli that surround it
Measured: pre-drug and 3 hours post-drug administration
Cognitive Function Tests - Picture Sequence
Picture sequence memory- Participants are shown a number of activities, and then asked to reproduce the sequence of pictures as it was presented to them.
Measured: pre-drug and 3 hours post-drug administration
Cognitive Function Tests - Sorting
List sorting working memory -a sequencing task requiring to sort information and sequence it
Measured: pre-drug and 3 hours post-drug administration
Cognitive Function Tests - Vocab
Picture vocabulary test- to measure the receptive (hearing) vocabulary of English-speaking adults
Measured: pre-drug and 3 hours post-drug administration
Cognitive Function Tests - Oral Reading
Oral reading recognition test- participants see a letter or word onscreen and must pronounce or identify it.
Measured: pre-drug and 3 hours post-drug administration
Cognitive Function Tests - Card Sort
Dimensional change card sort test- participants switch from sorting cards one way (e.g., by color) to sorting them a different way (e.g., by shape)
Measured: pre-drug and 3 hours post-drug administration
Cognitive Function Tests - pattern processing
Pattern comparison processing speed test- measures speed of processing by asking participants to discern whether two sideby-side pictures are the same or not.
Measured: pre-drug and 3 hours post-drug administration
Cognitive Function Tests - Auditory learning
Auditory learning verbal test- Five presentations of a 15-word list are given, each followed by attempted recall.
Measured: pre-drug and 3 hours post-drug administration
Cognitive Function Tests - Oral symbol
Oral symbol digit test- given 120 seconds to orally match symbols with digits as quickly as possible.
Measured: pre-drug and 3 hours post-drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start1 May 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Services for the AgedStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Within-subject design
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alison Oliveto, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055309
- Sponsor's protocol ID
- 275234
- Status last verified
- Dec 2025
- First submitted
- 12 Sep 2023
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Pharmacology of Cannabis in Older Adults: A Pilot Study
- ClinicalTrials.gov ID
- NCT06055309
- Acronym / sponsor ID
- 275234
- Conditions
- Health Services for the Aged
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the effects of cannabis on mood, cognitive and psychomotor performance, balance and vital signs in older adults.
Detailed description
The overarching aims of this pilot study are to determine the dose-related effects of cannabis and explore feasibility and acceptability of conducting a rigorous behavioral pharmacology study in this population. Using a within-subject design in older adults (55-70 years), this study will (1) determine acute dose-related effects of cannabis on physiological, subjective, cognitive, and psychomotor measures and (2) explore acceptability/feasibility of this approach among older adults in order to refine procedures for future studies. Volunteers (55-70 years) will undergo three 7.5-hour experimental sessions conducted one week apart, in which they receive cannabis containing various oral doses of tetrahydrocannabinol (THC) / cannabidiol (CBD) administered in a brownie formulation and the following are assessed: 1) self-reported and/or observer ratings of positive and negative subjective effects; 2) performance effects, measured by reaction time, coordination, and cognitive impairment; and 3) cardiovascular effects. Participants will be contacted the day after each session for feedback on the acceptability of session length, types, number and duration of tasks and any adverse events. Reasons for dropout will also be sought to determine whether study procedures impacted attrition. Findings will: 1) provide investigative team with the hands-on research cannabis research experience; 2) elucidate the optimal THC dose range; and 3) determine the most feasible/acceptable study design in older adults that will inform further rigorous studies examining acute and chronic administration of cannabis formulations among older adults.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Within-subject design
| Arm | Type | Receives |
|---|---|---|
| Cannabis (up to three doses) | Experimental | Drug: Cannabis (up to three doses)Brownies containing a dose of cannabis |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (14 listed)
- 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 tachycardia; 2nd degree, Mobitz type II heart block; 3rd degree heart block; left or right bundle branch block; pre-existing severe gastrointestinal narrowing (pathologic or iatrogenic)
- Have a serious and uncontrolled medical condition (major cardiovascular, renal, endocrine, or hepatic disorder) including a history of serious head trauma or neurological disorder (e.g., seizure disorder)
- Meet Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for lifetime psychosis, schizophrenia, or bipolar disorder or current major depressive disorder, suicidality (e.g., last month suicidal ideation or suicide attempt in past year, as measured by Columbia Suicide Severity Rating Scale) or have significant psychiatric symptoms of another disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabis (up to three doses)a dose of cannabis will be baked into brownies | Drug | Cannabis (up to three doses) |
Primary outcome
Vital Signs - Blood Pressure
Time frame: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration
systolic/diastolic blood pressure (mmHg)
Vital Signs - Respiration
Time frame: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration
respiration rate (breaths per minute)
Vital Signs - Pulse
Time frame: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration
pulse (beats per minute)
Self/Observer Ratings - Pain
Time frame: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration
Visual Analog Scales (making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain")
Self/Observer Ratings - Side Effects
Time frame: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration
Side Effects Ratings
Self/Observer Ratings - POMS
Time frame: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration
Profile of Mood States (POMS) short form - using a five-point scale ranging from "not at all" to "extremely."
Self/Observer Ratings - CADSS
Time frame: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration
Clinician Administered Dissociative Symptoms Scale (CADSS)-
Self/Observer Ratings - PROMIS
Time frame: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration
Patient Reported Outcomes Measurements Information System (PROMIS) Cognitive Function short form v2
Balance Tests - Four-Stage
Time frame: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration
The Four-Stage Balance Test- When the patient is steady, let go, and time how long they can maintain the position, but remain ready to assist the patient if they should lose their balance.
Balance Tests - Timed Up and Go
Time frame: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration
The Timed Up \& Go Test- Timing commences on the command 'go' and stops when the subject's back is positioned against the back of the chair after sitting down.
Balance Tests - 30 sec chair-stand
Time frame: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration
The 30-Second Chair-Stand Test- the number of times the patient comes to a full standing position in 30 seconds.
9 secondary outcomes
Cognitive Function Tests - Flanker
Time frame: pre-drug and 3 hours post-drug administration
Cognitive Function Tests - Picture Sequence
Time frame: pre-drug and 3 hours post-drug administration
Cognitive Function Tests - Sorting
Time frame: pre-drug and 3 hours post-drug administration
Cognitive Function Tests - Vocab
Time frame: pre-drug and 3 hours post-drug administration
Cognitive Function Tests - Oral Reading
Time frame: pre-drug and 3 hours post-drug administration
Cognitive Function Tests - Card Sort
Time frame: pre-drug and 3 hours post-drug administration
Cognitive Function Tests - pattern processing
Time frame: pre-drug and 3 hours post-drug administration
Cognitive Function Tests - Auditory learning
Time frame: pre-drug and 3 hours post-drug administration
Cognitive Function Tests - Oral symbol
Time frame: pre-drug and 3 hours post-drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Oliveto, PhD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cannabis (up to three doses) in people with Health Services for the Aged, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vital Signs - Blood Pressure (time frame: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.