Cannabidiol and Older Adult Cannabis Users

Last updated: May 6, 2024
Sponsor: University of Colorado, Boulder
Overall Status: Active - Recruiting

Phase

2

Condition

Pain

Depression

Substance Abuse

Treatment

Placebo

fsCBD Cannabidiol

bsCBD Cannabidiol

Clinical Study ID

NCT06290063
22-08-0138
  • Ages > 60
  • All Genders

Study 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 Criteria

Inclusion

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 6months
  • Female participants must be postmenopausal
  • Liver function tests (Alanine transaminase (ALT) and
  • Aspartate transaminase (AST)) must show levels no greater than 2x the upper normallimits for age
  • Must be currently taking medication/s for pain, sleep, and/or mood

Exclusion

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 orfail 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)

Study Design

Total Participants: 385
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 2
Study Start date:
May 01, 2024
Estimated Completion Date:
August 31, 2028

Connect with a study center

  • University of Colorado at Boulder

    Boulder, Colorado 80309
    United States

    Active - Recruiting

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