Cannabidiol and Older Adult Cannabis Users

Depression Clinical Trial

— QUARTz  

Official title:

Rocky Mountain Cannabis Research Center - Cannabidiol and Older Adult Cannabis Users: A Randomized, Placebo-Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06290063
• Other study ID #: 22-08-0138
• Status: Recruiting
• Phase: Phase 2
• Start date: May 1, 2024
• Est. completion date: August 31, 2028

Study information

• Verified date: May 2024
• Source: University of Colorado, Boulder
• Contact: Kyle A Chrystal, BA
• Phone: 6037697718
• Email: kyle.chrystal[@]colorado.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 385
• Est. completion date: August 31, 2028
• Est. primary completion date: August 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Anxiety
• Depression
• Marijuana Abuse
• Pain
• Sleep

Intervention

Drug:
• fsCBD Cannabidiol
Full Spectrum hemp-derived CBD (fsCBD; 200mg CBD/4mg THC) capsules produced by Ecofibre/Ananda Hemp will be used
• bsCBD Cannabidiol
Broad spectrum hemp-derived CBD (bsCBD; 200mg CBD) capsules produced by Ecofibre/Ananda Hemp will be used
• Placebo
Placebo arm; capsules produced by Ecofibre/Ananda Hemp will be used

Locations

Country	Name	City	State
United States	University of Colorado at Boulder	Boulder	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Boulder

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Blood Cytokine Levels	Blood cytokine levels will be measured from biological samples. Includes blood levels of cytokine inflammatory markers (IL6, TNF-a, IL-ß, and CRP)	Baseline, 4 weeks, 8 weeks
Primary	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
Primary	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
Primary	Inhibitory Control	Flanker Inhibitory Control and Attention Task	Baseline, 4 weeks, 8 weeks
Primary	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
Primary	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
Primary	Cognitive Ability	Digital Symbol Substitution Test (DSST) assesses global cognitive ability	Baseline, 4 weeks, 8 weeks
Primary	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
Primary	Change in Condition	Patient Global Impression of Change (PGIC). 7 point scale assessing subjective changes in participant's condition.	4 weeks, 8 weeks
Primary	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
Primary	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
Primary	Memory	Rey auditory verbal learning test assesses verbal memory.	Baseline, 4 weeks, 8 weeks
Secondary	Polypharmacy-Pain Medications	Use of pain medications	Baseline, 4 weeks, 8 weeks
Secondary	Polypharmacy-Psychiatric Medications	Use of psychiatric medications	Baseline, 4 weeks, 8 weeks
Secondary	Polypharmacy-Sleep Medications	Use of sleep medications	Baseline, 4 weeks, 8 weeks
Secondary	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
Secondary	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