Behavioral Pharmacology of Cannabis in Older Adults

NCT06055309 | Completed Phase 1 FDA Drug

• 1 other identifier: 275234
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Health Services for the Aged

Outcome Measures

Primary Outcomes (11)

• 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

• 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

Secondary Outcomes (9)

• Cognitive Function Tests - Flanker

  pre-drug and 3 hours post-drug administration

• Cognitive Function Tests - Picture Sequence

  pre-drug and 3 hours post-drug administration

• Cognitive Function Tests - Sorting

  pre-drug and 3 hours post-drug administration

• Cognitive Function Tests - Vocab

  pre-drug and 3 hours post-drug administration

• Cognitive Function Tests - Oral Reading

  pre-drug and 3 hours post-drug administration

Other Outcomes (9)

• Acceptability - session length

  1 day after sessions 1, 2, and 3

• Acceptability - ride service

  1 day after sessions 1, 2, and 3

• Acceptability - types of assessments

  1 day after sessions 1, 2, and 3

Study Arms (1)

Cannabis (up to three doses)

EXPERIMENTAL

Brownies containing a dose of cannabis

Drug: Cannabis (up to three doses)

Interventions

Cannabis (up to three doses) DRUG

a dose of cannabis will be baked into brownies

Cannabis (up to three doses)

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Science

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Interventions

nabiximols

Study Officials

• Alison Oliveto, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: brownies will contain different doses of cannabis product
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Within-subject design

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 26, 2023
• Study Start: May 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 14, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)