Cannabidiol and Older Adult Cannabis Users

NCT06290063 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 22-08-0138
• Study Type: interventional
• Target: 385
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (16)

• Subjective Motor Function

  Activities-specific Balance Confidence Scale. Participants asked about confidence in completion of 16 daily tasks without losing balance or becoming unsteady. Responses are on a scale from no confidence to completely confident, with higher aggregate scores meaning higher subjective motor function.

  Baseline, 4 weeks, 8 weeks

• Balance

  Dynamic sway (balance) measured via an app on a standard smartphone which will be attached to the participant's waist using a Velcro strap.

  Baseline, 4 weeks, 8 weeks

• Anxiety

  Beck Anxiety Inventory. 21 question survey. Each question is answered from 0 (not at all) to 3 (severely), where higher scores suggest higher anxiety. Total scores are between 0-63, where anything above 36 suggest potentially concerning levels of anxiety.

  Baseline, 4 weeks, 8 weeks

• Depression

  Beck Depression Inventory. 21 question survey. Each question is answered from 0 (not at all) to 3 (severely), where higher scores suggest higher depression. Total scores are between 0-63, where anything above 40 suggest potentially concerning levels of depression.

  Baseline, 4 weeks, 8 weeks

• Blood Cytokine Levels

  Blood cytokine levels will be measured from biological samples. Includes blood levels of cytokine inflammatory markers (IL6, TNF-α, IL-β, and CRP)

  Baseline, 4 weeks, 8 weeks

• Depression/Anxiety

  Depression Anxiety Stress Scale - 21 Item (DASS-21). Scores are between 0 and 63, with higher scores indicating more negative emotional states.

  Baseline, 4 weeks, 8 weeks

• Drug Effects

  Drug Effects Questionnaire (DEQ). Six questions about drug effects with possible answers of "not at all", "somewhat", and "extremely", where higher scores indicate higher drug effects.

  4 weeks, 8 weeks

• Inhibitory Control

  Flanker Inhibitory Control and Attention Task

  Baseline, 4 weeks, 8 weeks

• Cognitive Function

  Functional Assessment of Cognitive Function - Cognitive (FACT-Cog). Scores are transformed such that scores range from 0-132 and higher scores indicate a better quality of life/cognitive function.

  Baseline, 4 weeks, 8 weeks

• Pain Intensity and Interference

  Brief Pain Inventory - Short Form (BPI - SF). Measures pain levels, pain interference, and relief from medication, and includes diagrams for labeling pain.

  Baseline, 4 Weeks, 8 Weeks

• Cognitive Ability

  Digital Symbol Substitution Test (DSST) assesses global cognitive ability

  Baseline, 4 weeks, 8 weeks

• Pain Intensity

  PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Intensity (7-day). Scores are between 1-5, with 1 being no pain and 5 being very severe. Assessed with 2 items as well as current pain.

  Baseline, 4 weeks, 8 weeks

• Change in Condition

  Patient Global Impression of Change (PGIC). 7 point scale assessing subjective changes in participant's condition.

  4 weeks, 8 weeks

• Sleep Disturbance

  PROMIS (Patient-Reported Outcomes Measurement Information System) Sleep Disturbance 4a. Scores are separated between the first question (sleep quality) and the remaining 7 questions. For the first question, scores are between 1 and 5, with 1 being very poor sleep quality and 5 being very good sleep quality. The remaining 7 questions are scored individually on a scale of 1--5; for some questions, higher scores mean less disturbance, and for others, a higher score means more disturbance.

  Baseline, 4 weeks, 8 weeks

• Sleep-Related Impairment

  PROMIS (Patient-Reported Outcomes Measurement Information System) Sleep-Related Impairment 4a. Scores are between 4 and 20, with higher scores indicating more sleep-related impairment

  Baseline, 4 weeks, 8 weeks

• Memory

  Rey auditory verbal learning test assesses verbal memory.

  Baseline, 4 weeks, 8 weeks

Secondary Outcomes (5)

• Polypharmacy-Pain Medications

  Baseline, 4 weeks, 8 weeks

• Polypharmacy-Psychiatric Medications

  Baseline, 4 weeks, 8 weeks

• Polypharmacy-Sleep Medications

  Baseline, 4 weeks, 8 weeks

• Strength and Endurance

  Baseline, 4 weeks, 8 weeks

• Sleep Quality

  Baseline, 4 weeks, 8 weeks

Study Arms (3)

Full-Spectrum Hemp-Derived CBD (fsCBD)

EXPERIMENTAL

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

Drug: fsCBD Cannabidiol

Broad-Spectrum Hemp-Derived CBD (bsCBD)

EXPERIMENTAL

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

Drug: bsCBD Cannabidiol

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

fsCBD Cannabidiol DRUG

Full Spectrum hemp-derived CBD (fsCBD; 200mg CBD/4mg THC) capsules produced by Ecofibre/Ananda Hemp will be used

Full-Spectrum Hemp-Derived CBD (fsCBD)

bsCBD Cannabidiol DRUG

Broad spectrum hemp-derived CBD (bsCBD; 200mg CBD) capsules produced by Ecofibre/Ananda Hemp will be used

Broad-Spectrum Hemp-Derived CBD (bsCBD)

Placebo DRUG

Placebo arm; capsules produced by Ecofibre/Ananda Hemp will be used

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Colorado, Boulder: lead

Study Sites (1)

University of Colorado at Boulder

Boulder, Colorado, 80309, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depression; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Kyle A Chrystal, BA

CONTACT

6037697718; kyle.chrystal@colorado.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 4, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)