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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full-Spectrum Hemp-Derived CBD (fsCBD) | Experimental | 8 weeks of use of a daily dose of cannabis (200mg CBD/4mg THC) |
|
| Broad-Spectrum Hemp-Derived CBD (bsCBD) | Experimental | 8 weeks of use of a daily dose of cannabis (200mg CBD) |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fsCBD Cannabidiol | Drug | Full Spectrum hemp-derived CBD (fsCBD; 200mg CBD/4mg THC) capsules produced by Ecofibre/Ananda Hemp will be used |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Polypharmacy-Pain Medications | Use of pain medications | Baseline, 4 weeks, 8 weeks |
| Polypharmacy-Psychiatric Medications | Use of psychiatric medications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kyle A Chrystal, BA | Contact | 6037697718 | kyle.chrystal@colorado.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado at Boulder | Recruiting | Boulder | Colorado | 80309 | United States |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D009461 | Neurologic Manifestations |
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| bsCBD Cannabidiol | Drug | Broad spectrum hemp-derived CBD (bsCBD; 200mg CBD) capsules produced by Ecofibre/Ananda Hemp will be used |
|
| Placebo | Drug | Placebo arm; capsules produced by Ecofibre/Ananda Hemp will be used |
|
| 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 |
| Baseline, 4 weeks, 8 weeks |
| Polypharmacy-Sleep Medications | Use of sleep medications | Baseline, 4 weeks, 8 weeks |
| Strength and Endurance | 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. | Baseline, 4 weeks, 8 weeks |
| Sleep Quality | PSQI (Pittsburgh Sleep Quality Index) measures quality and patterns of sleep. Global scores range from 0-21 with higher scores indicating worse sleep quality. | Baseline, 4 weeks, 8 weeks |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |