Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
60 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
385 (estimated)
Sponsor
University of Colorado, Boulder · Other
Who this trial is looking for
This trial is looking for older adults who want to use cannabis for pain, anxiety, or mood issues. Participants will try different forms of cannabis or a placebo over 8 weeks to see how they work.
Are You a Good Fit for This Trial?
Must be takingPain medicationSleep medicationMood medication
You may be able to join if
I am at least 60 years old
I can give informed consent
I have used cannabis before with no negative effects
I haven't used cannabis regularly in the last 6 months
I am postmenopausal
My liver function tests are normal
I am currently taking medication for pain, sleep, or mood
You may not be able to join if
I have a blood alcohol level over 0 at screening
I have used drugs like cocaine or methamphetamine in the last 90 days
I have a history of psychosis in myself or my family
I am currently taking anti-epileptic medications
I am taking medications that interact with Epidiolex
I am currently using antipsychotic medications
I am undergoing chemotherapy
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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
* Li…
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)
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.