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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cannabis (up to three doses) | Experimental | Brownies containing a dose of cannabis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabis (up to three doses) | Drug | a dose of cannabis will be baked into brownies |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vital Signs - Blood Pressure | systolic/diastolic blood pressure (mmHg) | pre-drug and 1, 2, 3, and 5.5 hours post-drug administration |
| Vital Signs - Respiration | respiration rate (breaths per minute) | pre-drug and 1, 2, 3, and 5.5 hours post-drug administration |
| Vital Signs - Pulse | pulse (beats per minute) | 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") | pre-drug and 1, 2, 3, and 5.5 hours post-drug administration |
| Self/Observer Ratings - Side Effects | Side Effects Ratings | 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." | pre-drug and 1, 2, 3, and 5.5 hours post-drug administration |
| Self/Observer Ratings - CADSS | Clinician Administered Dissociative Symptoms Scale (CADSS)- | pre-drug and 1, 2, 3, and 5.5 hours post-drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | pre-drug and 3 hours post-drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability - session length | session length- Likert Scale (0 [not at all acceptable]-5 [completely acceptable]) | 1 day after sessions 1, 2, and 3 |
| Acceptability - ride service | ride service- Likert Scale (0 [not at all acceptable]-5 [completely acceptable]) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alison Oliveto, PhD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Science | Little Rock | Arkansas | 72205 | United States |
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| ID | Term |
|---|---|
| C587251 | nabiximols |
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Within-subject design
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brownies will contain different doses of cannabis product
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| Self/Observer Ratings - PROMIS |
Patient Reported Outcomes Measurements Information System (PROMIS) Cognitive Function short form v2 |
| 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. | 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. | 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. | pre-drug and 1, 2, 3, and 5.5 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. |
| 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 | 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 | 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. | 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) | 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. | 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. | 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. | pre-drug and 3 hours post-drug administration |
| 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]) | 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]) | 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]) | 1 day after sessions 1, 2, and 3 |
| Acceptability - wait times | wait times- Likert Scale (0 [not at all acceptable]-5 [completely acceptable]) | 1 day after sessions 1, 2, and 3 |
| Acceptability- activities | activities between assessment cycles- Likert Scale (0 [not at all acceptable]-5 [completely acceptable]) | 1 day after sessions 1, 2, and 3 |
| Acceptability - food | food- Likert Scale (0 [not at all acceptable]-5 [completely acceptable]) | 1 day after sessions 1, 2, and 3 |
| Acceptability - AEs | Adverse Events- Likert Scale (0 [not at all acceptable]-5 [completely acceptable]) | 1 day after sessions 1, 2, and 3 |