Actively Recruiting

Phase 2
Age: 60Years +
All Genders
NCT06290063

Cannabidiol and Older Adult Cannabis Users

Led by University of Colorado, Boulder · Updated on 2024-05-08

385

Participants Needed

1

Research Sites

226 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Cannabidiol and Older Adult Cannabis Users

Who Can Participate

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 (ALT and 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
Not Eligible

You will not qualify if you...

  • 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)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

University of Colorado at Boulder

Boulder, Colorado, United States, 80309

Actively Recruiting

Loading map...

Research Team

K

Kyle A Chrystal, BA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Cannabidiol and Older Adult Cannabis Users | DecenTrialz