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Behavioral Pharmacology of Cannabis in Older Adults

Primary Purpose

Health Services for the Aged

Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cannabis (up to three doses)
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Health Services for the Aged

Eligibility Criteria

55 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Arkansas for Medical Science

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cannabis (up to three doses)

Arm Description

Brownies containing a dose of cannabis

Outcomes

Primary Outcome Measures

Vital Signs - Blood Pressure
systolic/diastolic blood pressure (mmHg)
Vital Signs - Respiration
respiration rate (breaths per minute)
Vital Signs - Pulse
pulse (beats per minute)
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")
Self/Observer Ratings - Side Effects
Side Effects Ratings
Self/Observer Ratings - POMS
Profile of Mood States (POMS) short form - using a five-point scale ranging from "not at all" to "extremely."
Self/Observer Ratings - CADSS
Clinician Administered Dissociative Symptoms Scale (CADSS)-
Self/Observer Ratings - PROMIS
Patient Reported Outcomes Measurements Information System (PROMIS) Cognitive Function short form v2
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.
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.
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.

Secondary Outcome Measures

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
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.
Cognitive Function Tests - Sorting
List sorting working memory -a sequencing task requiring to sort information and sequence it.
Cognitive Function Tests - Vocab
Picture vocabulary test- to measure the receptive (hearing) vocabulary of English-speaking adults
Cognitive Function Tests - Oral Reading
Oral reading recognition test- participants see a letter or word onscreen and must pronounce or identify it.
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)
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.
Cognitive Function Tests - Auditory learning
Auditory learning verbal test- Five presentations of a 15-word list are given, each followed by attempted recall.
Cognitive Function Tests - Oral symbol
Oral symbol digit test- given 120 seconds to orally match symbols with digits as quickly as possible.

Full Information

First Posted
September 12, 2023
Last Updated
September 19, 2023
Sponsor
University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT06055309
Brief Title
Behavioral Pharmacology of Cannabis in Older Adults
Official Title
Behavioral Pharmacology of Cannabis in Older Adults: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health Services for the Aged

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Within-subject design
Masking
None (Open Label)
Masking Description
brownies will contain different doses of cannabis product
Allocation
N/A
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cannabis (up to three doses)
Arm Type
Experimental
Arm Description
Brownies containing a dose of cannabis
Intervention Type
Drug
Intervention Name(s)
Cannabis (up to three doses)
Intervention Description
a dose of cannabis will be baked into brownies
Primary Outcome Measure Information:
Title
Vital Signs - Blood Pressure
Description
systolic/diastolic blood pressure (mmHg)
Time Frame
pre-drug and 1, 2, 3, and 5.5 hours post-drug administration
Title
Vital Signs - Respiration
Description
respiration rate (breaths per minute)
Time Frame
pre-drug and 1, 2, 3, and 5.5 hours post-drug administration
Title
Vital Signs - Pulse
Description
pulse (beats per minute)
Time Frame
pre-drug and 1, 2, 3, and 5.5 hours post-drug administration
Title
Self/Observer Ratings - Pain
Description
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
Title
Self/Observer Ratings - Side Effects
Description
Side Effects Ratings
Time Frame
pre-drug and 1, 2, 3, and 5.5 hours post-drug administration
Title
Self/Observer Ratings - POMS
Description
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
Title
Self/Observer Ratings - CADSS
Description
Clinician Administered Dissociative Symptoms Scale (CADSS)-
Time Frame
pre-drug and 1, 2, 3, and 5.5 hours post-drug administration
Title
Self/Observer Ratings - PROMIS
Description
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
Title
Balance Tests - Four-Stage
Description
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
Title
Balance Tests - Timed Up and Go
Description
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
Title
Balance Tests - 30 sec chair-stand
Description
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
Secondary Outcome Measure Information:
Title
Cognitive Function Tests - Flanker
Description
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
Title
Cognitive Function Tests - Picture Sequence
Description
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
Title
Cognitive Function Tests - Sorting
Description
List sorting working memory -a sequencing task requiring to sort information and sequence it.
Time Frame
pre-drug and 3 hours post-drug administration
Title
Cognitive Function Tests - Vocab
Description
Picture vocabulary test- to measure the receptive (hearing) vocabulary of English-speaking adults
Time Frame
pre-drug and 3 hours post-drug administration
Title
Cognitive Function Tests - Oral Reading
Description
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
Title
Cognitive Function Tests - Card Sort
Description
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
Title
Cognitive Function Tests - pattern processing
Description
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
Title
Cognitive Function Tests - Auditory learning
Description
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
Title
Cognitive Function Tests - Oral symbol
Description
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
Other Pre-specified Outcome Measures:
Title
Acceptability - session length
Description
session length- Likert Scale (0 [not at all acceptable]-5 [completely acceptable])
Time Frame
1 day after sessions 1, 2, and 3
Title
Acceptability - ride service
Description
ride service- Likert Scale (0 [not at all acceptable]-5 [completely acceptable])
Time Frame
1 day after sessions 1, 2, and 3
Title
Acceptability - types of assessments
Description
types of assessments- Likert Scale (0 [not at all acceptable]-5 [completely acceptable])
Time Frame
1 day after sessions 1, 2, and 3
Title
Acceptability - frequency of assessments
Description
frequency of assessments- Likert Scale (0 [not at all acceptable]-5 [completely acceptable])
Time Frame
1 day after sessions 1, 2, and 3
Title
Acceptability - duration of assessments
Description
duration of assessments- Likert Scale (0 [not at all acceptable]-5 [completely acceptable])
Time Frame
1 day after sessions 1, 2, and 3
Title
Acceptability - wait times
Description
wait times- Likert Scale (0 [not at all acceptable]-5 [completely acceptable])
Time Frame
1 day after sessions 1, 2, and 3
Title
Acceptability- activities
Description
activities between assessment cycles- Likert Scale (0 [not at all acceptable]-5 [completely acceptable])
Time Frame
1 day after sessions 1, 2, and 3
Title
Acceptability - food
Description
food- Likert Scale (0 [not at all acceptable]-5 [completely acceptable])
Time Frame
1 day after sessions 1, 2, and 3
Title
Acceptability - AEs
Description
Adverse Events- Likert Scale (0 [not at all acceptable]-5 [completely acceptable])
Time Frame
1 day after sessions 1, 2, and 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Russell, PhD
Phone
501-526-8488
Email
LNRUSSELL@UAMS.EDU
First Name & Middle Initial & Last Name or Official Title & Degree
Alison Oliveto, PhD
Phone
501-526-8441
Email
OlivetoAlison@uams.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alison Oliveto, PhD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Science
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alison Oliveto, PhD
Phone
501-526-8441
Email
olivetoalison@uams.edu
First Name & Middle Initial & Last Name & Degree
Lauren Russell, PhD
Phone
501-526-8488
Email
lnrussell@uams.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Behavioral Pharmacology of Cannabis in Older Adults

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