Behavioral Pharmacology of Cannabis in Older Adults

• ClinicalTrials.gov Identifier: NCT06055309
• Recruitment Status: Not yet recruiting
• First Posted: September 26, 2023
• Last Update Posted: February 16, 2024
• Sponsor: University of Arkansas
• Information provided by (Responsible Party): University of Arkansas

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Health Services for the Aged	Drug: Cannabis (up to three doses)	Phase 1

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Within-subject design
• Masking: None (Open Label)
• Masking Description: brownies will contain different doses of cannabis product
• Primary Purpose: Basic Science
• Official Title: Behavioral Pharmacology of Cannabis in Older Adults: A Pilot Study
• Estimated Study Start Date: July 2024
• Estimated Primary Completion Date: December 2024
• Estimated Study Completion Date: December 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Cannabis (up to three doses); Brownies containing a dose of cannabis	Drug: Cannabis (up to three doses); a dose of cannabis will be baked into brownies

Outcome Measures

Primary Outcome Measures :

1. Vital Signs - Blood Pressure [ Time Frame: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration ]
   systolic/diastolic blood pressure (mmHg)
2. Vital Signs - Respiration [ Time Frame: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration ]
   respiration rate (breaths per minute)
3. Vital Signs - Pulse [ Time Frame: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration ]
   pulse (beats per minute)
4. 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")
5. Self/Observer Ratings - Side Effects [ Time Frame: pre-drug and 1, 2, 3, and 5.5 hours post-drug administration ]
   Side Effects Ratings
6. 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."
7. 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)-
8. 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
9. 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.
10. 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.
11. 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.

Secondary Outcome Measures :

1. Cognitive Function Tests - Flanker [ Time Frame: pre-drug and 3 hours post-drug administration ]
   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
2. Cognitive Function Tests - Picture Sequence [ Time Frame: pre-drug and 3 hours post-drug administration ]
   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.
3. Cognitive Function Tests - Sorting [ Time Frame: pre-drug and 3 hours post-drug administration ]
   List sorting working memory -a sequencing task requiring to sort information and sequence it.
4. Cognitive Function Tests - Vocab [ Time Frame: pre-drug and 3 hours post-drug administration ]
   Picture vocabulary test- to measure the receptive (hearing) vocabulary of English-speaking adults
5. Cognitive Function Tests - Oral Reading [ Time Frame: pre-drug and 3 hours post-drug administration ]
   Oral reading recognition test- participants see a letter or word onscreen and must pronounce or identify it.
6. Cognitive Function Tests - Card Sort [ Time Frame: pre-drug and 3 hours post-drug administration ]
   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)
7. Cognitive Function Tests - pattern processing [ Time Frame: pre-drug and 3 hours post-drug administration ]
   Pattern comparison processing speed test- measures speed of processing by asking participants to discern whether two sideby-side pictures are the same or not.
8. Cognitive Function Tests - Auditory learning [ Time Frame: pre-drug and 3 hours post-drug administration ]
   Auditory learning verbal test- Five presentations of a 15-word list are given, each followed by attempted recall.
9. Cognitive Function Tests - Oral symbol [ Time Frame: pre-drug and 3 hours post-drug administration ]
   Oral symbol digit test- given 120 seconds to orally match symbols with digits as quickly as possible.

Other Outcome Measures:

1. Acceptability - session length [ Time Frame: 1 day after sessions 1, 2, and 3 ]
   session length- Likert Scale (0 [not at all acceptable]-5 [completely acceptable])
2. Acceptability - ride service [ Time Frame: 1 day after sessions 1, 2, and 3 ]
   ride service- Likert Scale (0 [not at all acceptable]-5 [completely acceptable])
3. Acceptability - types of assessments [ Time Frame: 1 day after sessions 1, 2, and 3 ]
   types of assessments- Likert Scale (0 [not at all acceptable]-5 [completely acceptable])
4. Acceptability - frequency of assessments [ Time Frame: 1 day after sessions 1, 2, and 3 ]
   frequency of assessments- Likert Scale (0 [not at all acceptable]-5 [completely acceptable])
5. Acceptability - duration of assessments [ Time Frame: 1 day after sessions 1, 2, and 3 ]
   duration of assessments- Likert Scale (0 [not at all acceptable]-5 [completely acceptable])
6. Acceptability - wait times [ Time Frame: 1 day after sessions 1, 2, and 3 ]
   wait times- Likert Scale (0 [not at all acceptable]-5 [completely acceptable])
7. Acceptability- activities [ Time Frame: 1 day after sessions 1, 2, and 3 ]
   activities between assessment cycles- Likert Scale (0 [not at all acceptable]-5 [completely acceptable])
8. Acceptability - food [ Time Frame: 1 day after sessions 1, 2, and 3 ]
   food- Likert Scale (0 [not at all acceptable]-5 [completely acceptable])
9. Acceptability - AEs [ Time Frame: 1 day after sessions 1, 2, and 3 ]
   Adverse Events- Likert Scale (0 [not at all acceptable]-5 [completely acceptable])

Eligibility Criteria

• Ages Eligible for Study: 55 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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 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
• 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)

Contacts and Locations

Contacts

Contact: Lauren Russell, PhD; 501-526-8488; LNRUSSELL@UAMS.EDU

Contact: Alison Oliveto, PhD; 501-526-8441; OlivetoAlison@uams.edu

Locations

United States, Arkansas

University of Arkansas for Medical Science

Little Rock, Arkansas, United States, 72205

Contact: Alison Oliveto, PhD 501-526-8441 olivetoalison@uams.edu

Contact: Lauren Russell, PhD 501-526-8488 lnrussell@uams.edu

Sponsors and Collaborators

University of Arkansas

Investigators

• Principal Investigator: Alison Oliveto, PhD; University of Arkansas

More Information

• Responsible Party: University of Arkansas
• ClinicalTrials.gov Identifier: NCT06055309
• Other Study ID Numbers: 275234
• First Posted: September 26, 2023
• Last Update Posted: February 16, 2024
• Last Verified: August 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No