RECRUITING

Cannabidiol and Older Adult Cannabis Users

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Conditions

SleepAnxietyDepressionPain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Rocky Mountain Cannabis Research Center - Cannabidiol and Older Adult Cannabis Users: A Randomized, Placebo-Controlled Study

Quick Facts

Study Start:2024-05-01
Study Completion:2028-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06290063

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * At least 60 years of age
  2. * Able to provide informed consent
  3. * Must have used a cannabis product at least once with no negative effects
  4. * Must not have been regularly using any cannabis products (\<3x/month) in the last 6 months
  5. * Female participants must be postmenopausal
  6. * Liver function tests (Alanine transaminase (ALT) and
  7. * Aspartate transaminase (AST)) must show levels no greater than 2x the upper normal limits for age
  8. * Must be currently taking medication/s for pain, sleep, and/or mood
  1. * Blood alcohol level \> 0 at screening (to sign consent form)
  2. * Report of other drug use (cocaine, opiates, methamphetamine) in the past 90 days or fail urine screen for any of these drugs
  3. * Past or current diagnosis, or family history of diagnosis of psychosis
  4. * Current use of anti-epileptic medications (e.g. clobazam, sodium valproate)
  5. * Current use of medications known to have major interactions with Epidiolex (buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, and/or teriflunomide).
  6. * Current use of antipsychotic medications
  7. * Currently undergoing chemotherapy (to prevent drug interactions)

Contacts and Locations

Study Contact

Kyle A Chrystal, BA
CONTACT
6037697718
kyle.chrystal@colorado.edu

Study Locations (Sites)

University of Colorado at Boulder
Boulder, Colorado, 80309
United States

Collaborators and Investigators

Sponsor: University of Colorado, Boulder

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-01
Study Completion Date2028-08-31

Study Record Updates

Study Start Date2024-05-01
Study Completion Date2028-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Sleep
  • Anxiety
  • Depression
  • Pain