NCT06290063 Cannabidiol and Older Adult Cannabis Users
| NCT ID | NCT06290063 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Colorado, Boulder |
| Condition | Sleep |
| Study Type | INTERVENTIONAL |
| Enrollment | 385 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2028-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 385 participants in total. It began in 2024-05-01 with a primary completion date of 2028-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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, 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.
Eligibility Criteria
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06290063 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Sleep. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06290063 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06290063 currently recruiting?
Yes, NCT06290063 is actively recruiting participants. Contact the research team at kyle.chrystal@colorado.edu for enrollment information.
Where is the NCT06290063 trial being conducted?
This trial is being conducted at Boulder, United States.
Who is sponsoring the NCT06290063 clinical trial?
NCT06290063 is sponsored by University of Colorado, Boulder. The trial plans to enroll 385 participants.