Effects of cannabis on older adults' health and performance
Behavioral Pharmacology of Cannabis in Older Adults: A Pilot Study
This study tests how different amounts of cannabis in brownies affect mood, thinking, balance, and health in older adults aged 55 to 70.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 55 Years to 70 Years |
| Sex | All |
| Sponsor | University of Arkansas Academic / other |
| Locations | 1 site (Little Rock, Arkansas) |
| Trial ID | NCT06055309 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates how different doses of cannabis affect mood, cognitive and psychomotor performance, balance, and vital signs in older adults aged 55-70. Participants will undergo three experimental sessions where they will receive varying doses of THC and CBD in a brownie formulation. The study aims to assess both the physiological and subjective effects of cannabis, as well as the feasibility and acceptability of the study design among older adults. Feedback will be collected post-session to refine future research procedures.
Who should consider this trial
Good fit: Ideal candidates are older adults aged 55-70 with a self-reported history of marijuana use and no serious adverse effects.
Not a fit: Patients with serious medical conditions or those currently using psychoactive drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the safe use of cannabis for improving health outcomes in older adults.
How similar studies have performed: While there is limited research specifically on older adults, similar studies on cannabis effects in younger populations have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Little Rock, Arkansas
- University of Arkansas for Medical Science — Little Rock, Arkansas, United States (Recruiting)
Study contacts
- Principal investigator: Alison Oliveto, PhD — University of Arkansas
- Study coordinator: Lauren Russell, PhD
- Email: LNRUSSELL@UAMS.EDU
- Phone: 501-526-8488
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.