RECRUITING

Novel Approaches to Assessing Cannabis Impaired Driving (NAACID)

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Researchers at the University of Colorado Anschutz Medical Campus, Colorado School of Public Health, and Injury \& Violence Prevention Center want to learn more about how people are affected by cannabis in different ways. We will use a driving simulator to compare the driving performance of adults who use cannabis daily, occasionally or have not recently used cannabis.

Official Title

Novel Approaches to Assessing Cannabis Impaired Driving

Quick Facts

Study Start:2020-06-20

Study Completion:2025-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06255054

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Not specified

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* The following are inclusion criteria for participants to be enrolled in any of the four phases of the study: 1. Participants who are ≥21 years old and ≤55 years old 2. Participants who are able to provide written, informed consent 3. Participants with active healthcare coverage (including health insurance, Medicaid, etc.) 4. Participants who are willing to complete up to two in-person study visits (one for Phases 1 \& 2, and two for Phases 3 \& 4), including up to two urine drug screens, two alcohol breathalyzer tests, and one urine pregnancy test (if applicable) 5. Participants who agree to refrain from using non-prescription psychotropic drugs (e.g., ecstasy), hallucinogens, and synthetic cannabinoids during the study 6. Participants who agree to refrain from drinking \>3 alcoholic drinks the day prior to the data collection study visit (the single visit for Phases 1 \& 2, and the second visit for Phases 3 \& 4) 7. Participants who agree to refrain from using any cannabis products for at least 8 hours prior to the data collection study visit (the single visit for Phases 1 \& 2, and the second visit for Phases 3 \& 4) 8. Participants who are willing to provide and use their own cannabis product that has been procured from a licensed dispensary, is labeled with THC potency, and contains \<2% CBD (cannabis use groups only; the single visit for Phases 1 \& 2, and the second visit for Phases 3 \& 4) 9. Participants who agree to have a sober driver pick them up after the data collection study visit (cannabis use groups only; the single visit for Phases 1 \& 2, and the second visit for Phases 3 \& 4) 10. Participants who take at least 2 inhalations ("hits") during their typical inhalational (smoking/vaporizing) sessions, or ingest at least 5 mg of THC when they consume edible cannabis products (cannabis use groups only) 11. Participants who are willing to provide a sample of their cannabis to be independently tested for potency and terpene content (Phases 1, 3 \& 4 only)	* The following are exclusion criteria for participants to be enrolled in any of the four phases of the study: 1. Prisoners 2. Participants who have nocturnal schedules (e.g., work night shifts) 3. Participants with a history of abuse or addiction to substances other than cannabis (e.g., prescription and non-prescription pharmaceuticals, alcohol, or illicit drugs) 4. Participants who have expressed an interest in substance abuse treatment within the 60 days prior to study enrollment 5. Participants who report consuming an average of \>3 alcoholic drinks per day in the 30 days prior to study enrollment 6. Participants with any past or current diagnosis of schizophrenia, narcolepsy, heart disease, epilepsy, or a traumatic brain injury 7. Participants who are currently experiencing untreated bipolar disorder, major depression, sleep apnea, or other uncontrolled medical conditions as determined by the investigators (e.g., hypertension) 8. Participants with a known balance or gait disorder 9. Participants with color blindness (Phase 2 only) 10. Participants who currently wear hard contact lenses for vision correction (Phase 2 only) 11. Participants who have donated 450 mL or more of blood in the two weeks prior to study enrollment 12. Participants who are pregnant or breastfeeding (female participants only) 13. Participants who report never using cannabis before in their lifetime (Phases 1 \& 2 only) 14. Participants with a history of clinically significant adverse event(s) associated with cannabis intoxication (e.g., lightheadedness, nausea, dizziness, etc., cannabis use groups only) 15. Participants with uncorrected visual acuity disorder, defined as binocular vision worse than 20/40 (Phases 2, 3 \& 4 only; determined at screening) 16. Participants with a body mass index \>40 kg/m2 (determined at screening) 17. Participants with a positive breath alcohol test (breathalyzer) at screening 18. Participants who are otherwise unsuitable for inclusion in the study, based on the opinion of the investigator

Inclusion Criteria

Exclusion Criteria

* The following are inclusion criteria for participants to be enrolled in any of the four phases of the study:
1. Participants who are ≥21 years old and ≤55 years old
2. Participants who are able to provide written, informed consent
3. Participants with active healthcare coverage (including health insurance, Medicaid, etc.)
4. Participants who are willing to complete up to two in-person study visits (one for Phases 1 \& 2, and two for Phases 3 \& 4), including up to two urine drug screens, two alcohol breathalyzer tests, and one urine pregnancy test (if applicable)
5. Participants who agree to refrain from using non-prescription psychotropic drugs (e.g., ecstasy), hallucinogens, and synthetic cannabinoids during the study
6. Participants who agree to refrain from drinking \>3 alcoholic drinks the day prior to the data collection study visit (the single visit for Phases 1 \& 2, and the second visit for Phases 3 \& 4)
7. Participants who agree to refrain from using any cannabis products for at least 8 hours prior to the data collection study visit (the single visit for Phases 1 \& 2, and the second visit for Phases 3 \& 4)
8. Participants who are willing to provide and use their own cannabis product that has been procured from a licensed dispensary, is labeled with THC potency, and contains \<2% CBD (cannabis use groups only; the single visit for Phases 1 \& 2, and the second visit for Phases 3 \& 4)
9. Participants who agree to have a sober driver pick them up after the data collection study visit (cannabis use groups only; the single visit for Phases 1 \& 2, and the second visit for Phases 3 \& 4)
10. Participants who take at least 2 inhalations ("hits") during their typical inhalational (smoking/vaporizing) sessions, or ingest at least 5 mg of THC when they consume edible cannabis products (cannabis use groups only)
11. Participants who are willing to provide a sample of their cannabis to be independently tested for potency and terpene content (Phases 1, 3 \& 4 only)

* The following are exclusion criteria for participants to be enrolled in any of the four phases of the study:
1. Prisoners
2. Participants who have nocturnal schedules (e.g., work night shifts)
3. Participants with a history of abuse or addiction to substances other than cannabis (e.g., prescription and non-prescription pharmaceuticals, alcohol, or illicit drugs)
4. Participants who have expressed an interest in substance abuse treatment within the 60 days prior to study enrollment
5. Participants who report consuming an average of \>3 alcoholic drinks per day in the 30 days prior to study enrollment
6. Participants with any past or current diagnosis of schizophrenia, narcolepsy, heart disease, epilepsy, or a traumatic brain injury
7. Participants who are currently experiencing untreated bipolar disorder, major depression, sleep apnea, or other uncontrolled medical conditions as determined by the investigators (e.g., hypertension)
8. Participants with a known balance or gait disorder
9. Participants with color blindness (Phase 2 only)
10. Participants who currently wear hard contact lenses for vision correction (Phase 2 only)
11. Participants who have donated 450 mL or more of blood in the two weeks prior to study enrollment
12. Participants who are pregnant or breastfeeding (female participants only)
13. Participants who report never using cannabis before in their lifetime (Phases 1 \& 2 only)
14. Participants with a history of clinically significant adverse event(s) associated with cannabis intoxication (e.g., lightheadedness, nausea, dizziness, etc., cannabis use groups only)
15. Participants with uncorrected visual acuity disorder, defined as binocular vision worse than 20/40 (Phases 2, 3 \& 4 only; determined at screening)
16. Participants with a body mass index \>40 kg/m2 (determined at screening)
17. Participants with a positive breath alcohol test (breathalyzer) at screening
18. Participants who are otherwise unsuitable for inclusion in the study, based on the opinion of the investigator

Contacts and Locations

Study Contact

Sarah A Limbacher, MPH

CONTACT

4406377882

sarah.limbacher@cuanschutz.edu

Ashley Brooks-Russell, PhD, MPH

CONTACT

303-724-8437

ashley.brooks-russell@cuanschutz.edu

Study Locations (Sites)

Driving Study Lab

Denver, Colorado, 80220

United States

Collaborators and Investigators

Sponsor: Colorado School of Public Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-06-20

Study Completion Date2025-05

Study Record Updates

Study Start Date2020-06-20

Study Completion Date2025-05

Terms related to this study

Keywords Provided by Researchers

Driving Impairment

Additional Relevant MeSH Terms

Cannabis Use