RecruitingPhase 2NCT06290063

Cannabidiol and Older Adult Cannabis Users

Rocky Mountain Cannabis Research Center - Cannabidiol and Older Adult Cannabis Users: A Randomized, Placebo-Controlled Study


Sponsor

University of Colorado, Boulder

Enrollment

385 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how a non-psychoactive component of cannabis called CBD (cannabidiol) affects older adults who use cannabis occasionally. Researchers want to understand whether CBD can help with pain, sleep, or mood in people aged 60 and older. **You may be eligible if...** - You are at least 60 years old - You have tried a cannabis product at least once without negative effects - You have NOT used cannabis regularly (less than 3 times per month) in the past 6 months - You are currently taking medication for pain, sleep, or mood - You are a postmenopausal woman (if female) - Your liver function tests are within acceptable range **You may NOT be eligible if...** - You have used cocaine, opioids, or methamphetamine in the past 90 days - You have a personal or family history of certain psychiatric conditions - You have a blood alcohol level above zero at screening Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGfsCBD Cannabidiol

Full Spectrum hemp-derived CBD (fsCBD; 200mg CBD/4mg THC) capsules produced by Ecofibre/Ananda Hemp will be used

DRUGbsCBD Cannabidiol

Broad spectrum hemp-derived CBD (bsCBD; 200mg CBD) capsules produced by Ecofibre/Ananda Hemp will be used

DRUGPlacebo

Placebo arm; capsules produced by Ecofibre/Ananda Hemp will be used


Locations(1)

University of Colorado at Boulder

Boulder, Colorado, United States

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NCT06290063


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