Novel Approaches to Assessing Cannabis Impaired Driving (NAACID)

NCT ID: NCT06255054

Last Updated: 2024-02-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 130 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-20
• Study Completion Date: 2025-05-31

Brief Summary

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.

Conditions

Cannabis Use

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: PROSPECTIVE

Study Groups

Non-Users

People who do not use cannabis.

No interventions assigned to this group

Daily Flower Users

People who use cannabis flower daily.

No interventions assigned to this group

Daily Concentrate Users

People who use cannabis concentrate products daily.

No interventions assigned to this group

Occasional Flower Users

People who use cannabis flower at least once a month and no more than three times per week.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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)

Exclusion Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Colorado School of Public Health

OTHER

Sponsor Role: lead

Responsible Party

Ashley Brooks-Russell

Associate Professor, Director (Injury and Violence Prevention Center)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Driving Study Lab

Denver, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sarah A Limbacher, MPH

Role: CONTACT

sarah.limbacher@cuanschutz.edu

4406377882

Ashley Brooks-Russell, PhD, MPH

Role: CONTACT

ashley.brooks-russell@cuanschutz.edu

303-724-8437

Facility Contacts

Sarah A Limbacher, MPH

Role: primary

sarah.limbacher@cuanschutz.edu

440-637-7882

Other Identifiers

ColoradoSPH

Identifier Type: -

Identifier Source: org_study_id