Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
385 participants
INTERVENTIONAL
2024-05-01
2028-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Full-Spectrum Hemp-Derived CBD (fsCBD)
8 weeks of use of a daily dose of cannabis (200mg CBD/4mg THC)
fsCBD Cannabidiol
Full Spectrum hemp-derived CBD (fsCBD; 200mg CBD/4mg THC) capsules produced by Ecofibre/Ananda Hemp will be used
Broad-Spectrum Hemp-Derived CBD (bsCBD)
8 weeks of use of a daily dose of cannabis (200mg CBD)
bsCBD Cannabidiol
Broad spectrum hemp-derived CBD (bsCBD; 200mg CBD) capsules produced by Ecofibre/Ananda Hemp will be used
Placebo
Placebo
Placebo arm; capsules produced by Ecofibre/Ananda Hemp will be used
Interventions
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fsCBD Cannabidiol
Full Spectrum hemp-derived CBD (fsCBD; 200mg CBD/4mg THC) capsules produced by Ecofibre/Ananda Hemp will be used
bsCBD Cannabidiol
Broad spectrum hemp-derived CBD (bsCBD; 200mg CBD) capsules produced by Ecofibre/Ananda Hemp will be used
Placebo
Placebo arm; capsules produced by Ecofibre/Ananda Hemp will be used
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
60 Years
ALL
No
Sponsors
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University of Colorado, Boulder
OTHER
Responsible Party
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Angela Bryan
Professor
Locations
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University of Colorado at Boulder
Boulder, Colorado, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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22-08-0138
Identifier Type: -
Identifier Source: org_study_id
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