Aging and Marijuana: Benefits, Effects, and Risks

Cannabis Use Clinical Trial

— AMBER  

Official title:

Cannabis Use Among Older Adults: Potential Risks and Benefits to an Aging Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05188404
• Other study ID #: 1R01AG066698
• Status: Recruiting
• Start date: September 20, 2021
• Est. completion date: January 31, 2026

Study information

• Verified date: October 2023
• Source: University of Colorado, Boulder
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Investigators will gather data on both the beneficial and harmful effects of edible cannabis of varying composition (THC-only vs. CBD-only vs. THC+CBD), and will examine the process by which older adult cannabis users decide what type of cannabis product is preferred.

Description:

Older adults are currently the fastest growing group of cannabis users in the U.S, and are more likely to use cannabis for medicinal purposes (e.g., pain, trouble sleeping, depression/anxiety) than for recreational purposes, despite having little data to guide their decisions about what type of product to use. This project utilizes a patient-centered observational design to recruit and assess older adults who are interested in using cannabis compared to a control group who is not interested in cannabis use. Investigators will gather data on both the beneficial and harmful effects of edible cannabis of varying composition (THC-only vs. CBD-only vs. THC+CBD), and will examine the process by which older adult cannabis users decide what type of cannabis product is preferred.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: January 31, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• At least 60 years of age
• Able to provide informed consent
• Cannabis Users: Must not currently use cannabis more than 7 times per month and not for pain, sleep, depression or anxiety in the past 6 months
• Cannabis Non-users: Should NOT have used cannabis in the past year and have not used regularly (e.g., more than weekly) for more than one year in the past 20 years
• Cannabis Users: Must be interested in using cannabis for at least one of the following complains: pain, sleep problems, depression, anxiety
• Non-users: Must NOT be interested in using cannabis but have at least one of the following complaints: pain, sleep problems, depression, anxiety
• Cannabis users: must be comfortable using edible cannabis and having a mobile laboratory (Dodge van) parked at their home
• Female participants must be postmenopausal
• Comfortable reading and writing in English
• Planning to stay in the Boulder/Denver area for the next month
• Must be comfortable with blood draws

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 of psychosis
• Current use of antipsychotic medications
• Heavy drinking; Alcohol Use Disorder Identification Test (AUDIT) test score >8
• Inability/discomfort/unwillingness with getting in and out of the mobile laboratory van
• History of vertigo or falls within the past six months

Related Conditions & MeSH terms

• Cannabis Use
• Marijuana Abuse

Intervention

Behavioral:
• Choice of cannabis product
Participants choose and purchase their own cannabis product

Locations

Country	Name	City	State
United States	University of Colorado 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
Other	Change in Blood Cannabinoids and Endocannabinoids	Quantitation of major and minor cannabinoids and endocannabinoids in blood; measure of whether cannabinoid levels change over time	Baseline, 1-month
Other	Change in Neurofilament Light	Quantitation of neuronal damage in blood; measure of whether damage change over time	Baseline, 1-month
Other	Change in Expectancies about Cannabis	Self-report of whether opinions about the health effects of cannabis has improved, gotten worse, or stayed the same	Baseline, 1-month, 2 months, 3 months, 4 months
Other	Change in Flanker Inhibitory Control and Attention task	Measure of whether inhibition has improved, gotten worse, or stayed the same	Baseline, 1-month
Primary	Change in Patient Global Impression of Change	Self report of whether symptoms have improved, gotten worse, or stayed the same	1-month, 2 months, 3 months, 4 months
Primary	Change in FACT-Cog	Self-report of whether cognitive function has improved, gotten worse, or stayed the same	Baseline, 1-month, 2 months, 3 months, 4 months
Primary	Change in Rey Auditory Verbal Learning Task	Test of whether working memory has improved, gotten worse, or stayed the same	Baseline, 1-month
Primary	Balance Task	Stability with eyes closed and eyes open	1-month
Primary	Change in Activities Specific Balance Confidence Scale	Self-report of whether confidence in balance has improved, gotten worse, or stayed the same	Baseline, 1-month, 2 months, 3 months, 4 months
Secondary	Change in Depression Anxiety Stress Scale	Self-report of whether depression, anxiety and stress have improved, gotten worse, or stayed the same	Baseline, 1-month, 2 months, 3 months, 4 months
Secondary	Change in PROMIS Sleep Disturbance	Self-report of whether sleep quality has improved, gotten worse, or stayed the same	Baseline, 1-month, 2 months, 3 months, 4 months
Secondary	Change in PROMIS Fatigue	Measure of whether experience of fatigue has improved, gotten worse, or stayed the same	Baseline, 1-month, 2 months, 3 months, 4 months
Secondary	Change in PROMIS Pain Interference	Self-report of whether the extent to which pain interferes with daily life activities has improved, gotten worse, or stayed the same	Baseline, 1-month, 2 months, 3 months, 4 months
Secondary	Change in pain Intensity past 7 days	Self-report of whether intensity of pain has improved, gotten worse, or stayed the same	Baseline, 1-month, 2 months, 3 months, 4 months
Secondary	Current Pain Intensity	Self-reported intensity of pain right now	1-month
Secondary	Addiction Research Center Inventory Marijuana Survey	Acute subjective effects of cannabis	1-month
Secondary	Drug Effects Questionnaire	Acute subjective effects of cannabis	1-month
Secondary	Profile of Mood States	Acute mood effects of cannabis	1-month
Secondary	Change in PROMIS Global Health	Self-report of whether general health and functioning has improved, gotten worse, or stayed the same	Baseline, 1-month, 2 months, 3 months, 4 months
Secondary	Change in Polypharmacy	Measure of whether number and dosage of current medications has improved, gotten worse, or stayed the same	Baseline, 1-month, 2 months, 3 months, 4 months
Secondary	Change in Online Timeline Follow-back Assessment	30-day retrospective report of substance use (cannabis, alcohol, other drugs); measure of whether substance use has improved, gotten worse, or stayed the same	Baseline, 1-month, 2 months, 3 months, 4 months
Secondary	Change in Marijuana Consumption Questionnaire	Self-report of whether frequency and quantity of cannabis use changes over time or stays the same	Baseline, 1-month, 2 months, 3 months, 4 months