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NCT Number: NCT06290063

Cannabidiol and Older Adult Cannabis Users

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.

Recruiting

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Colorado at Boulder

Boulder, Colorado, 80309, United States

Location status: Recruiting

Location contact

Ellie Sundali, BA

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

fsCBD Cannabidiol

Drug

Full Spectrum hemp-derived CBD (fsCBD; 200mg CBD/4mg THC) capsules produced by Ecofibre/Ananda Hemp will be used

bsCBD Cannabidiol

Drug

Broad spectrum hemp-derived CBD (bsCBD; 200mg CBD) capsules produced by Ecofibre/Ananda Hemp will be used

Placebo

Drug

Placebo arm; capsules produced by Ecofibre/Ananda Hemp will be used

Primary outcomes

  1. Subjective Motor Function

    Time frame: Baseline, 4 weeks, 8 weeks

    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.

  2. Balance

    Time frame: Baseline, 4 weeks, 8 weeks

    Dynamic sway (balance) measured via an app on a standard smartphone which will be attached to the participant's waist using a Velcro strap.

  3. Anxiety

    Time frame: Baseline, 4 weeks, 8 weeks

    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.

  4. Depression

    Time frame: Baseline, 4 weeks, 8 weeks

    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.

  5. Blood Cytokine Levels

    Time frame: Baseline, 4 weeks, 8 weeks

    Blood cytokine levels will be measured from biological samples. Includes blood levels of cytokine inflammatory markers (IL6, TNF-α, IL-β, and CRP)

  6. Depression/Anxiety

    Time frame: Baseline, 4 weeks, 8 weeks

    Depression Anxiety Stress Scale - 21 Item (DASS-21). Scores are between 0 and 63, with higher scores indicating more negative emotional states.

  7. Drug Effects

    Time frame: 4 weeks, 8 weeks

    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.

  8. Inhibitory Control

    Time frame: Baseline, 4 weeks, 8 weeks

    Flanker Inhibitory Control and Attention Task

  9. Cognitive Function

    Time frame: Baseline, 4 weeks, 8 weeks

    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.

  10. Pain Intensity and Interference

    Time frame: Baseline, 4 Weeks, 8 Weeks

    Brief Pain Inventory - Short Form (BPI - SF). Measures pain levels, pain interference, and relief from medication, and includes diagrams for labeling pain.

  11. Cognitive Ability

    Time frame: Baseline, 4 weeks, 8 weeks

    Digital Symbol Substitution Test (DSST) assesses global cognitive ability

  12. Pain Intensity

    Time frame: Baseline, 4 weeks, 8 weeks

    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.

  13. Change in Condition

    Time frame: 4 weeks, 8 weeks

    Patient Global Impression of Change (PGIC). 7 point scale assessing subjective changes in participant's condition.

  14. Sleep Disturbance

    Time frame: Baseline, 4 weeks, 8 weeks

    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.

  15. Sleep-Related Impairment

    Time frame: Baseline, 4 weeks, 8 weeks

    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

  16. Memory

    Time frame: Baseline, 4 weeks, 8 weeks

    Rey auditory verbal learning test assesses verbal memory.

Secondary outcomes

  1. Polypharmacy-Pain Medications

    Time frame: Baseline, 4 weeks, 8 weeks

    Use of pain medications

  2. Polypharmacy-Psychiatric Medications

    Time frame: Baseline, 4 weeks, 8 weeks

    Use of psychiatric medications

  3. Polypharmacy-Sleep Medications

    Time frame: Baseline, 4 weeks, 8 weeks

    Use of sleep medications

  4. Strength and Endurance

    Time frame: Baseline, 4 weeks, 8 weeks

    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.

  5. Sleep Quality

    Time frame: Baseline, 4 weeks, 8 weeks

    PSQI (Pittsburgh Sleep Quality Index) measures quality and patterns of sleep. Global scores range from 0-21 with higher scores indicating worse sleep quality.

Study contacts

Contact information is provided by the study sponsor or research team.

Kyle A Chrystal, BA

CONTACT

[email protected]

6037697718

Sponsors and collaborators

Lead sponsor

University of Colorado, Boulder

Other

Registry information

Official study title

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

Acronym: QUARTz

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Mar 4, 2024
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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