Cannabidiol and Older Adult Cannabis Users (QUARTz)

Rocky Mountain Cannabis Research Center - Cannabidiol and Older Adult Cannabis Users: A Randomized, Placebo-Controlled Study

Cannabis use increased 10 fold among adults over the age of 65 between 2014 and 2016 but very little data exists on the extent of their harmful effects on health and behavior. The overarching goal of this project is to test a novel harm reduction strategy in which older individuals who seek to use cannabis for pain, anxiety or mood problems (depression/anxiety) will be randomly assigned to one of three conditions in an 8 week randomized controlled trial: hemp-derived CBD+THC, hemp-derived CBD-THC, or placebo. This work has the ability to directly inform individual choices regarding the use of cannabis products among older adults, and direct policy decisions regulating cannabis formulations on the legal market.

Study Overview

• Status: Recruiting
• Conditions: Depression; Pain; Sleep; Anxiety
• Intervention / Treatment: Drug: fsCBD Cannabidiol; Drug: bsCBD Cannabidiol; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 385
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Kyle A Chrystal, BA; Phone Number: 6037697718; Email: kyle.chrystal@colorado.edu

Study Locations

• United States
  • Colorado
    • Boulder, Colorado, United States, 80309
      • Recruiting
      • University of Colorado at Boulder
      • Contact: Ellie Sundali, BA; Email: ellie.sundali@colorado.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• At least 60 years of age
• Able to provide informed consent
• Must have used a cannabis product at least once with no negative effects
• Must not have been regularly using any cannabis products (<3x/month) in the last 6 months
• Female participants must be postmenopausal
• Liver function tests (Alanine transaminase (ALT) and
• Aspartate transaminase (AST)) must show levels no greater than 2x the upper normal limits for age
• Must be currently taking medication/s for pain, sleep, and/or mood

Exclusion Criteria:

• Blood alcohol level > 0 at screening (to sign consent form)
• Report of other drug use (cocaine, opiates, methamphetamine) in the past 90 days or fail urine screen for any of these drugs
• Past or current diagnosis, or family history of diagnosis of psychosis
• Current use of anti-epileptic medications (e.g. clobazam, sodium valproate)
• Current use of medications known to have major interactions with Epidiolex (buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, and/or teriflunomide).
• Current use of antipsychotic medications
• Currently undergoing chemotherapy (to prevent drug interactions)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo arm; capsules produced by Ecofibre/Ananda Hemp will be used
Experimental: Full-Spectrum Hemp-Derived CBD (fsCBD); 8 weeks of use of a daily dose of cannabis (200mg CBD/4mg THC)	Drug: fsCBD Cannabidiol; Full Spectrum hemp-derived CBD (fsCBD; 200mg CBD/4mg THC) capsules produced by Ecofibre/Ananda Hemp will be used
Experimental: Broad-Spectrum Hemp-Derived CBD (bsCBD); 8 weeks of use of a daily dose of cannabis (200mg CBD)	Drug: bsCBD Cannabidiol; Broad spectrum hemp-derived CBD (bsCBD; 200mg CBD) capsules produced by Ecofibre/Ananda Hemp will be used

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Disturbance	PROMIS (Patient-Reported Outcomes Measurement Information System) Sleep Disturbance 4a. Scores are separated between the first question (sleep quality) and the remaining 7 questions. For the first question, scores are between 1 and 5, with 1 being very poor sleep quality and 5 being very good sleep quality. The remaining 7 questions are scored individually on a scale of 1--5; for some questions, higher scores mean less disturbance, and for others, a higher score means more disturbance.	Baseline, 4 weeks, 8 weeks
Sleep-Related Impairment	PROMIS (Patient-Reported Outcomes Measurement Information System) Sleep-Related Impairment 4a. Scores are between 4 and 20, with higher scores indicating more sleep-related impairment	Baseline, 4 weeks, 8 weeks
Depression/Anxiety	Depression Anxiety Stress Scale - 21 Item (DASS-21). Scores are between 0 and 63, with higher scores indicating more negative emotional states.	Baseline, 4 weeks, 8 weeks
Cognitive Function	Functional Assessment of Cognitive Function - Cognitive (FACT-Cog). Scores are transformed such that scores range from 0-132 and higher scores indicate a better quality of life/cognitive function.	Baseline, 4 weeks, 8 weeks
Subjective Motor Function	Activities-specific Balance Confidence Scale. Participants asked about confidence in completion of 16 daily tasks without losing balance or becoming unsteady. Responses are on a scale from no confidence to completely confident, with higher aggregate scores meaning higher subjective motor function.	Baseline, 4 weeks, 8 weeks
Balance	Dynamic sway (balance) measured via an app on a standard smartphone which will be attached to the participant's waist using a Velcro strap.	Baseline, 4 weeks, 8 weeks
Anxiety	Beck Anxiety Inventory. 21 question survey. Each question is answered from 0 (not at all) to 3 (severely), where higher scores suggest higher anxiety. Total scores are between 0-63, where anything above 36 suggest potentially concerning levels of anxiety.	Baseline, 4 weeks, 8 weeks
Depression	Beck Depression Inventory. 21 question survey. Each question is answered from 0 (not at all) to 3 (severely), where higher scores suggest higher depression. Total scores are between 0-63, where anything above 40 suggest potentially concerning levels of depression.	Baseline, 4 weeks, 8 weeks
Blood Cytokine Levels	Blood cytokine levels will be measured from biological samples. Includes blood levels of cytokine inflammatory markers (IL6, TNF-α, IL-β, and CRP)	Baseline, 4 weeks, 8 weeks
Drug Effects	Drug Effects Questionnaire (DEQ). Six questions about drug effects with possible answers of "not at all", "somewhat", and "extremely", where higher scores indicate higher drug effects.	4 weeks, 8 weeks
Inhibitory Control	Flanker Inhibitory Control and Attention Task	Baseline, 4 weeks, 8 weeks
Pain Intensity and Interference	Brief Pain Inventory - Short Form (BPI - SF). Measures pain levels, pain interference, and relief from medication, and includes diagrams for labeling pain.	Baseline, 4 Weeks, 8 Weeks
Cognitive Ability	Digital Symbol Substitution Test (DSST) assesses global cognitive ability	Baseline, 4 weeks, 8 weeks
Pain Intensity	PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Intensity (7-day). Scores are between 1-5, with 1 being no pain and 5 being very severe. Assessed with 2 items as well as current pain.	Baseline, 4 weeks, 8 weeks
Change in Condition	Patient Global Impression of Change (PGIC). 7 point scale assessing subjective changes in participant's condition.	4 weeks, 8 weeks
Memory	Rey auditory verbal learning test assesses verbal memory.	Baseline, 4 weeks, 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Polypharmacy-Pain Medications	Use of pain medications	Baseline, 4 weeks, 8 weeks
Polypharmacy-Psychiatric Medications	Use of psychiatric medications	Baseline, 4 weeks, 8 weeks
Polypharmacy-Sleep Medications	Use of sleep medications	Baseline, 4 weeks, 8 weeks
Strength and Endurance	Leg strength and endurance measured with 30-second chair stand task. Participants are asked to stand up from a chair as many times as possible for 30 seconds.	Baseline, 4 weeks, 8 weeks
Sleep Quality	PSQI (Pittsburgh Sleep Quality Index) measures quality and patterns of sleep. Global scores range from 0-21 with higher scores indicating worse sleep quality.	Baseline, 4 weeks, 8 weeks

Collaborators and Investigators

• Sponsor: University of Colorado, Boulder

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: February 19, 2024
• First Submitted That Met QC Criteria: February 25, 2024
• First Posted (Actual): March 4, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Depression; Marijuana Abuse; Anticonvulsants; Cannabidiol
• Other Study ID Numbers: 22-08-0138

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No