fsCBD Cannabidiol
Full Spectrum hemp-derived CBD (fsCBD; 200mg CBD/4mg THC) capsules produced by Ecofibre/Ananda Hemp will be used
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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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-06-10
What this record can show
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Full Spectrum hemp-derived CBD (fsCBD; 200mg CBD/4mg THC) capsules produced by Ecofibre/Ananda Hemp will be used
Broad spectrum hemp-derived CBD (bsCBD; 200mg CBD) capsules produced by Ecofibre/Ananda Hemp will be used
Placebo arm; capsules produced by Ecofibre/Ananda Hemp will be used
Eligibility
primary outcomes
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.
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.
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.
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.
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)
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.
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.
Time frame: Baseline, 4 weeks, 8 weeks
Flanker Inhibitory Control and Attention Task
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.
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.
Time frame: Baseline, 4 weeks, 8 weeks
Digital Symbol Substitution Test (DSST) assesses global cognitive ability
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.
Time frame: 4 weeks, 8 weeks
Patient Global Impression of Change (PGIC). 7 point scale assessing subjective changes in participant's condition.
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.
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
Time frame: Baseline, 4 weeks, 8 weeks
Rey auditory verbal learning test assesses verbal memory.
secondary outcomes
Time frame: Baseline, 4 weeks, 8 weeks
Use of pain medications
Time frame: Baseline, 4 weeks, 8 weeks
Use of psychiatric medications
Time frame: Baseline, 4 weeks, 8 weeks
Use of sleep medications
Time frame: Baseline, 4 weeks, 8 weeks
Leg strength and endurance measured with 30-second chair stand task. Participants are asked to stand up from a chair as many times as possible for 30 seconds.
Time frame: Baseline, 4 weeks, 8 weeks
PSQI (Pittsburgh Sleep Quality Index) measures quality and patterns of sleep. Global scores range from 0-21 with higher scores indicating worse sleep quality.
Publications
No exact PMID-linked public article is currently readable locally.