A Phase 1 interventional study of Cannabis (up to three doses) in Health Services for the Aged, sponsored by University of Arkansas. Completed at 1 site in United States. Open to participants aged 55 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-14.
Sponsored by University of Arkansas · Phase 1, Interventional, and Basic science
This study examines the effects of cannabis on mood, cognitive and psychomotor performance, balance and vital signs in older adults.
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.
University of Arkansas is the lead sponsor of 391 studies on the registry; 39 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 34 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Brownies containing a dose of cannabis
Drug: Cannabis (up to three doses)
a dose of cannabis will be baked into brownies
Vital Signs - Blood Pressure
systolic/diastolic blood pressure (mmHg)
Time frame: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration
Vital Signs - Respiration
respiration rate (breaths per minute)
Time frame: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration
Vital Signs - Pulse
pulse (beats per minute)
Time frame: 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")
Time frame: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration
Self/Observer Ratings - Side Effects
Side Effects Ratings
Time frame: 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."
Time frame: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration
Self/Observer Ratings - CADSS
Clinician Administered Dissociative Symptoms Scale (CADSS)-
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration
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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: pre-drug and 3 hours post-drug administration
Acceptability - session length
session length- Likert Scale (0 \[not at all acceptable\]-5 \[completely acceptable\])
Time frame: 1 day after sessions 1, 2, and 3
Acceptability - ride service
ride service- Likert Scale (0 \[not at all acceptable\]-5 \[completely acceptable\])
Time frame: 1 day after sessions 1, 2, and 3
Acceptability - types of assessments
types of assessments- Likert Scale (0 \[not at all acceptable\]-5 \[completely acceptable\])
Time frame: 1 day after sessions 1, 2, and 3
Acceptability - frequency of assessments
frequency of assessments- Likert Scale (0 \[not at all acceptable\]-5 \[completely acceptable\])
Time frame: 1 day after sessions 1, 2, and 3
Acceptability - duration of assessments
duration of assessments- Likert Scale (0 \[not at all acceptable\]-5 \[completely acceptable\])
Time frame: 1 day after sessions 1, 2, and 3
Acceptability - wait times
wait times- Likert Scale (0 \[not at all acceptable\]-5 \[completely acceptable\])
Time frame: 1 day after sessions 1, 2, and 3
Acceptability- activities
activities between assessment cycles- Likert Scale (0 \[not at all acceptable\]-5 \[completely acceptable\])
Time frame: 1 day after sessions 1, 2, and 3
Acceptability - food
food- Likert Scale (0 \[not at all acceptable\]-5 \[completely acceptable\])
Time frame: 1 day after sessions 1, 2, and 3
Acceptability - AEs
Adverse Events- Likert Scale (0 \[not at all acceptable\]-5 \[completely acceptable\])
Time frame: 1 day after sessions 1, 2, and 3
Plan to share: No
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University of Arkansas