Cannabidiol and Older Adult Cannabis Users

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

Subjective Motor Function

Time frame: Baseline, 4 weeks, 8 weeks

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.

Balance

Time frame: Baseline, 4 weeks, 8 weeks

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

Anxiety

Time frame: Baseline, 4 weeks, 8 weeks

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.

Depression

Time frame: Baseline, 4 weeks, 8 weeks

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.

Blood Cytokine Levels

Time frame: Baseline, 4 weeks, 8 weeks

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

Depression/Anxiety

Time frame: Baseline, 4 weeks, 8 weeks

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

Drug Effects

Time frame: 4 weeks, 8 weeks

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.

Inhibitory Control

Time frame: Baseline, 4 weeks, 8 weeks

Flanker Inhibitory Control and Attention Task

Cognitive Function

Time frame: Baseline, 4 weeks, 8 weeks

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.

Pain Intensity and Interference

Time frame: Baseline, 4 Weeks, 8 Weeks

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

Cognitive Ability

Time frame: Baseline, 4 weeks, 8 weeks

Digital Symbol Substitution Test (DSST) assesses global cognitive ability

Pain Intensity

Time frame: Baseline, 4 weeks, 8 weeks

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.

Change in Condition

Time frame: 4 weeks, 8 weeks

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

Sleep Disturbance

Time frame: Baseline, 4 weeks, 8 weeks

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.

Sleep-Related Impairment

Time frame: Baseline, 4 weeks, 8 weeks

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

Memory

Time frame: Baseline, 4 weeks, 8 weeks

Rey auditory verbal learning test assesses verbal memory.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.