Testing CBD and THC for older adults using cannabis
Rocky Mountain Cannabis Research Center - Cannabidiol and Older Adult Cannabis Users: A Randomized, Placebo-Controlled Study
This study is testing if a mix of CBD and THC, just CBD, or a placebo can help older adults manage pain, anxiety, and depression while using cannabis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 385 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | University of Colorado, Boulder Academic / other |
| Drugs / interventions | pexidartinib, chemotherapy |
| Locations | 1 site (Boulder, Colorado) |
| Trial ID | NCT06290063 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the effects of hemp-derived CBD and THC on older adults who use cannabis for managing pain, anxiety, and depression. Participants aged 60 and above will be randomly assigned to receive either a combination of CBD and THC, CBD without THC, or a placebo over an 8-week period. The study seeks to gather data on the safety and efficacy of these cannabis formulations, which could inform personal choices and regulatory policies regarding cannabis use among older adults.
Who should consider this trial
Good fit: Ideal candidates are adults aged 60 and older who have previously used cannabis without negative effects and are currently taking medications for pain, sleep, or mood.
Not a fit: Patients with a history of psychosis or those currently using certain medications that interact with cannabis products may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into safe cannabis use for older adults, potentially improving their quality of life.
How similar studies have performed: While there is limited data on older adult cannabis use, similar studies exploring CBD and THC effects have shown promise, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Boulder, Colorado
- University of Colorado at Boulder — Boulder, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Kyle A Chrystal, BA
- Email: kyle.chrystal@colorado.edu
- Phone: 6037697718
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.