Testing CBD and THC for older adults using cannabis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.