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Search / Trial NCT06290063

Cannabidiol and Older Adult Cannabis Users

Launched by UNIVERSITY OF COLORADO, BOULDER · Feb 25, 2024

Trial Information

Current as of May 14, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the effects of different cannabis products on older adults who are using cannabis to help with issues like pain, anxiety, sleep problems, or depression. Specifically, researchers want to see if a combination of hemp-derived CBD (a compound from cannabis that doesn’t make you feel high) and THC (the compound that does) is beneficial compared to CBD alone or a placebo (a substance with no active ingredients). The trial will last for eight weeks, and participants will be randomly assigned to one of these three groups.

To qualify for the study, participants need to be at least 60 years old, must have used cannabis at least once before without negative effects, and currently be taking medication for pain, sleep, or mood. However, they should not have used cannabis regularly in the last six months. It's important to note that individuals with certain medical conditions or those taking specific medications may not be eligible. If you decide to participate, you can help researchers understand how cannabis products may affect older adults, which could influence choices and regulations regarding cannabis use in the future.

Gender

ALL

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
  • 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)

About University Of Colorado, Boulder

The University of Colorado Boulder is a leading research institution recognized for its commitment to advancing knowledge and innovation in various fields, including health sciences. With a robust infrastructure for clinical research, the university fosters interdisciplinary collaboration among experts, facilitating the development and implementation of clinical trials that address critical health challenges. Its state-of-the-art facilities and dedication to ethical research practices ensure high standards in participant care and data integrity, making it a prominent sponsor in the clinical trial landscape.

Locations

Boulder, Colorado, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported