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Recruiting NCT06290063

Cannabidiol and Older Adult Cannabis Users

Phase II Interventional Sleep Anxiety Depression Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: fsCBD Cannabidiol, bsCBD Cannabidiol, Placebo.
Who it may be relevant to
Registry conditions: Sleep, Anxiety, Depression, Pain. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug fsCBD Cannabidiol
    Full Spectrum hemp-derived CBD (fsCBD; 200mg CBD/4mg THC) capsules produced by Ecofibre/Ananda Hemp will be used
  • Drug bsCBD Cannabidiol
    Broad spectrum hemp-derived CBD (bsCBD; 200mg CBD) capsules produced by Ecofibre/Ananda Hemp will be used
  • Drug Placebo
    Placebo arm; capsules produced by Ecofibre/Ananda Hemp will be used

Primary outcome measures

  • Subjective Motor Function [Time frame: Baseline, 4 weeks, 8 weeks]
  • Balance [Time frame: Baseline, 4 weeks, 8 weeks]
  • Anxiety [Time frame: Baseline, 4 weeks, 8 weeks]
  • Depression [Time frame: Baseline, 4 weeks, 8 weeks]
  • Blood Cytokine Levels [Time frame: Baseline, 4 weeks, 8 weeks]
  • Depression/Anxiety [Time frame: Baseline, 4 weeks, 8 weeks]
  • Drug Effects [Time frame: 4 weeks, 8 weeks]
  • Inhibitory Control [Time frame: Baseline, 4 weeks, 8 weeks]
  • Cognitive Function [Time frame: Baseline, 4 weeks, 8 weeks]
  • Pain Intensity and Interference [Time frame: Baseline, 4 Weeks, 8 Weeks]
Secondary outcome measures (5)
  • Polypharmacy-Pain Medications [Time frame: Baseline, 4 weeks, 8 weeks]
  • Polypharmacy-Psychiatric Medications [Time frame: Baseline, 4 weeks, 8 weeks]
  • Polypharmacy-Sleep Medications [Time frame: Baseline, 4 weeks, 8 weeks]
  • Strength and Endurance [Time frame: Baseline, 4 weeks, 8 weeks]
  • Sleep Quality [Time frame: Baseline, 4 weeks, 8 weeks]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Colorado at Boulder — Boulder

Identifiers

NCT: NCT06290063 · 22-08-0138

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗