Aging and Marijuana: Benefits, Effects, and Risks (AMBER)

University of Colorado Boulder (CU)

Status: Completed

Conditions: Cannabis Use

Treatments: Behavioral: Choice of cannabis product

Study type: Observational

Funder types: Other

Identifiers

NCT05188404

1R01AG066698

Details and patient eligibility

About

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.

Full 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.

Enrollment: 326 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

326 participants in 2 patient groups

Cannabis Users

Description:

Older adults (60 and up) who report pain, sleep problems, and/or negative mood (anxiety and/or depression) and who desire to use cannabis for these issues (n=300)

Treatment:

Behavioral: Choice of cannabis product

Cannabis Non-users

Description:

Older adults (60 and up) who report pain, sleep problems, and/or negative mood (anxiety and/or depression) and do NOT desire to use cannabis for these issues (n=50)