SleepPhase 2QUARTzNCT06290063
Cannabidiol and Older Adult Cannabis Users
A Phase 2 study testing fsCBD Cannabidiol and bsCBD Cannabidiol in people with Sleep and Anxiety, run by University of Colorado, Boulder at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Sleep, Anxiety, Depression
- What is being tested?
- fsCBD Cannabidiol and bsCBD Cannabidiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 385 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to 31 Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado at Boulder
Boulder, Colorado, 80309
Ellie Sundali, BA, ellie.sundali@colorado.edu
About this study
Official title: 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.
- Conditions
- Sleep, Anxiety, Depression, Pain
- Being tested
- fsCBD Cannabidiol, bsCBD Cannabidiol, Placebo
- Medical subject headings
- Anxiety Disorders, Depression, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fsCBD CannabidiolDrug
Full Spectrum hemp-derived CBD (fsCBD; 200mg CBD/4mg THC) capsules produced by Ecofibre/Ananda Hemp will be used
bsCBD CannabidiolDrug
Broad spectrum hemp-derived CBD (bsCBD; 200mg CBD) capsules produced by Ecofibre/Ananda Hemp will be used
PlaceboDrug
Placebo arm; capsules produced by Ecofibre/Ananda Hemp will be used
| Study group | Role | What they receive |
|---|---|---|
| Full-Spectrum Hemp-Derived CBD (fsCBD) | Experimental | 8 weeks of use of a daily dose of cannabis (200mg CBD/4mg THC) Receives: Drug: fsCBD Cannabidiol |
| Broad-Spectrum Hemp-Derived CBD (bsCBD) | Experimental | 8 weeks of use of a daily dose of cannabis (200mg CBD) Receives: Drug: bsCBD Cannabidiol |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 4 weeks, 8 weeks
Inhibitory Control
Flanker Inhibitory Control and Attention Task
Measured: 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.
Measured: 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.
Measured: Baseline, 4 Weeks, 8 Weeks
Cognitive Ability
Digital Symbol Substitution Test (DSST) assesses global cognitive ability
Measured: 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.
Measured: Baseline, 4 weeks, 8 weeks
Change in Condition
Patient Global Impression of Change (PGIC). 7 point scale assessing subjective changes in participant's condition.
Measured: 4 weeks, 8 weeks
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.
Measured: 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
Measured: Baseline, 4 weeks, 8 weeks
Memory
Rey auditory verbal learning test assesses verbal memory.
Measured: Baseline, 4 weeks, 8 weeks
Secondary outcomes (5)
Polypharmacy-Pain Medications
Use of pain medications
Measured: Baseline, 4 weeks, 8 weeks
Polypharmacy-Psychiatric Medications
Use of psychiatric medications
Measured: Baseline, 4 weeks, 8 weeks
Polypharmacy-Sleep Medications
Use of sleep medications
Measured: 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.
Measured: 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.
Measured: Baseline, 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start1 May 2024
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 385 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Bryan, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290063
- Sponsor's protocol ID
- 22-08-0138
- Acronym
- QUARTz
- Status last verified
- Jun 2026
- First submitted
- 19 Feb 2024
- Last updated
- 10 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rocky Mountain Cannabis Research Center - Cannabidiol and Older Adult Cannabis Users: A Randomized, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT06290063
- Acronym / sponsor ID
- QUARTz / 22-08-0138
- Conditions
- Sleep, Anxiety, Depression, Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 385 participants (estimated)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Full-Spectrum Hemp-Derived CBD (fsCBD) | Experimental | Drug: fsCBD Cannabidiol8 weeks of use of a daily dose of cannabis (200mg CBD/4mg THC) |
| Broad-Spectrum Hemp-Derived CBD (bsCBD) | Experimental | Drug: bsCBD Cannabidiol8 weeks of use of a daily dose of cannabis (200mg CBD) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fsCBD CannabidiolFull Spectrum hemp-derived CBD (fsCBD; 200mg CBD/4mg THC) capsules produced by Ecofibre/Ananda Hemp will be used | Drug | Full-Spectrum Hemp-Derived CBD (fsCBD) |
| bsCBD CannabidiolBroad spectrum hemp-derived CBD (bsCBD; 200mg CBD) capsules produced by Ecofibre/Ananda Hemp will be used | Drug | Broad-Spectrum Hemp-Derived CBD (bsCBD) |
| PlaceboPlacebo arm; capsules produced by Ecofibre/Ananda Hemp will be used | Drug | Placebo |
Primary outcome
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.
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.
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.
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.
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)
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.
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.
Inhibitory Control
Time frame: Baseline, 4 weeks, 8 weeks
Flanker Inhibitory Control and Attention Task
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.
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.
Cognitive Ability
Time frame: Baseline, 4 weeks, 8 weeks
Digital Symbol Substitution Test (DSST) assesses global cognitive ability
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.
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.
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.
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
Memory
Time frame: Baseline, 4 weeks, 8 weeks
Rey auditory verbal learning test assesses verbal memory.
5 secondary outcomes
Polypharmacy-Pain Medications
Time frame: Baseline, 4 weeks, 8 weeks
Polypharmacy-Psychiatric Medications
Time frame: Baseline, 4 weeks, 8 weeks
Polypharmacy-Sleep Medications
Time frame: Baseline, 4 weeks, 8 weeks
Strength and Endurance
Time frame: Baseline, 4 weeks, 8 weeks
Sleep Quality
Time frame: Baseline, 4 weeks, 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Sleep
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fsCBD Cannabidiol and bsCBD Cannabidiol in people with Sleep and Anxiety, run by University of Colorado, Boulder at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kyle A Chrystal, BA (6037697718, kyle.chrystal@colorado.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Motor Function (time frame: Baseline, 4 weeks, 8 weeks). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.