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New treatment option for Sleep
Official title Cannabidiol and Older Adult Cannabis Users
ClinicalTrials.gov ID: NCT06290063
What this study is testing
What is fsCBD Cannabidiol?
fsCBD Cannabidiol is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for sleep.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- Current use of antipsychotic medications
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Boulder, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boulder, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.