NCT05084105

Brief Summary

With increased availability and use of cannabis by older adults aged ≥ 50 years, a rigorous evaluation of the benefits and risks of cannabis use in these individuals is necessary. Our proposed project will investigate whether older adults who initiate cannabis use after the age of 50 are at an increased risk of fall and what are the underlying mechanisms. We will measure motor and cognitive function in older cannabis users and nonusers and we will use positron emission tomography to determine brain activity and how it is associated with fall risk.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 19, 2021

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

May 24, 2022

Status Verified

May 1, 2022

Enrollment Period

1.8 years

First QC Date

October 5, 2021

Last Update Submit

May 23, 2022

Conditions

Keywords

CannabisAgingFallsBrain Glucose Uptake

Outcome Measures

Primary Outcomes (2)

  • Fall Risk

    The following equation for the prediction of falls will be used: Likelihood of falling (%) = (exp (-7.519 + 0.026(reaction time) - 0.071(ABC1) - 2.139(Berg 14))) / (1 + exp (-7.519 + 0.026(reaction time) - 0.071(ABC1) - 2.139(Berg 14)) ×100)

    Through study completion, on average 1 year

  • Brain activity PET Imaging

    To investigate cerebral glucose uptake in older chronic cannabis users and non-users

    Through study completion, on average 1 year

Study Arms (2)

Cannabis Group

A total of 30 older (age 50-80 years) men and women who are using cannabis.

Control Group

A total of 30 older (age 50-80 years) men and women who are not using cannabis.

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

A total of 30 older (age 50-80 years) men and women who are using cannabis and 30 controls who are non-users, will be recruited.

You may qualify if:

  • years
  • Healthy enough to complete the protocol based on information obtained from a clinical exam and past medical history, such as cardiovascular diseases.
  • Comprehension of the protocol as indicated by an ability to respond to questions about the study after reading the consent form.
  • Able to use and be contacted by telephone.
  • Able to speak, read, and understand English, and complete a questionnaire in English

You may not qualify if:

  • Presence of pacemakers, aneurysm clips, artificial heart valves, metallic prostheses
  • Pregnancy
  • History of significant traumatic brain injury
  • Unable to lie flat for the study imaging

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Health and Human Physiology

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 5, 2021

First Posted

October 19, 2021

Study Start

February 1, 2020

Primary Completion

November 1, 2021

Study Completion

November 1, 2021

Last Updated

May 24, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations