COMPLETED

Behavioral Pharmacology of Cannabis in Older Adults

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Behavioral Pharmacology of Cannabis in Older Adults: A Pilot Study

Quick Facts

Study Start:2025-05-01

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06055309

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	* 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)

Inclusion Criteria

Exclusion 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)

* 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

Principal Investigator

Alison Oliveto, PhD

PRINCIPAL_INVESTIGATOR

University of Arkansas

Study Locations (Sites)

University of Arkansas for Medical Science

Little Rock, Arkansas, 72205

United States

Collaborators and Investigators

Sponsor: University of Arkansas

Alison Oliveto, PhD, PRINCIPAL_INVESTIGATOR, University of Arkansas

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-01

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2025-05-01

Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

Health Services for the Aged