Cannabidiol (CBD) and Older Adult Cannabis Users Study
This study is looking at how different types of cannabidiol (CBD) affect older adults who use cannabis. We want to understand if full spectrum CBD (fsCBD), which contains 200mg CBD and 4mg THC, or broad spectrum CBD (bsCBD), which has 200mg CBD without THC, can help with pain, anxiety, depression, and sleep. Participants will be randomly assigned to receive fsCBD, bsCBD, or a placebo (an inactive pill). We'll measure changes in your movement, balance, and anxiety levels over 8 weeks. You may be able to join if you are at least 60 years old, have used cannabis before without problems, and haven't used cannabis regularly in the last six months. Your liver function will also be checked.
- Study design
- This is an interventional study with 385 participants. Participants will be randomly assigned to one of three groups: fsCBD, bsCBD, or placebo.
- What's involved
- You would participate for 8 weeks, with measurements taken at the start, 4 weeks, and 8 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 8 weeks, with the last measurements taken at that time.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Cannabidiol and Older Adult Cannabis Users
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Subjective Motor FunctionBaseline, 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.
- BalanceBaseline, 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.
- AnxietyBaseline, 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.
- DepressionBaseline, 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 LevelsBaseline, 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/AnxietyBaseline, 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 Effects4 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 ControlBaseline, 4 weeks, 8 weeks
Flanker Inhibitory Control and Attention Task
- Cognitive FunctionBaseline, 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 InterferenceBaseline, 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 AbilityBaseline, 4 weeks, 8 weeks
Digital Symbol Substitution Test (DSST) assesses global cognitive ability
- Pain IntensityBaseline, 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 Condition4 weeks, 8 weeks
Patient Global Impression of Change (PGIC). 7 point scale assessing subjective changes in participant's condition.
- Sleep DisturbanceBaseline, 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 ImpairmentBaseline, 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
- MemoryBaseline, 4 weeks, 8 weeks
Rey auditory verbal learning test assesses verbal memory.