Recruiting
Phase 2

Cannabidiol

Sponsor:

University of Colorado, Boulder

Code:

NCT06290063

Conditions

Sleep

Anxiety

Depression

Pain

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

fsCBD Cannabidiol

bsCBD Cannabidiol

Placebo

Study Details

Brief 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.

Conditions

Sleep

Anxiety

Depression

Pain

Study ID

NCT06290063

Start date

May 1, 2024

Status verified date

Jun, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

385 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Full-Spectrum Hemp-Derived CBD (fsCBD)

8 weeks of use of a daily dose of cannabis (200mg CBD/4mg THC)

experimental: Broad-Spectrum Hemp-Derived CBD (bsCBD)

8 weeks of use of a daily dose of cannabis (200mg CBD)

placebo comparator: Placebo

Interventions

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

Primary outcome measure

  • 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 ]
  • Cognitive Ability [ Time Frame: Baseline, 4 weeks, 8 weeks ]
  • Pain Intensity [ Time Frame: Baseline, 4 weeks, 8 weeks ]
  • Change in Condition [ Time Frame: 4 weeks, 8 weeks ]
  • Sleep Disturbance [ Time Frame: Baseline, 4 weeks, 8 weeks ]
  • Sleep-Related Impairment [ Time Frame: Baseline, 4 weeks, 8 weeks ]
  • Memory [ Time Frame: Baseline, 4 weeks, 8 weeks ]

Central Contacts and Locations

Central contacts

Kyle A Chrystal, BA

6037697718kyle.chrystal@colorado.edu

Locations

University of Colorado at Boulder

Recruiting

Boulder, Colorado, United States, 80309

Contacts

Ellie Sundali, BA

ellie.sundali@colorado.edu

More Information

Sponsor

University of Colorado, Boulder

Last update posted

Jun 10, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Boulder on 2026-06-10.