Combined Alcohol and Cannabis Effects on Skills of Young Drivers

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03106363
• Date of registration: 04/04/2017
• Prospective Registration: Yes
• Primary sponsor: Centre for Addiction and Mental Health
• Public title: Combined Alcohol and Cannabis Effects on Skills of Young Drivers
• Scientific title: Effects of Combined Alcohol and Cannabis on Young Drivers' Simulated Driving
• Date of first enrolment: July 4, 2017
• Target sample size: 85
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03106363
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: Double (Participant, Investigator).
• Phase: Early Phase 1

Countries of recruitment

Canada

Contacts

• Name: Christine M Wickens, PhD
• Affiliation: Centre for Addiction and Mental Health

Key inclusion & exclusion criteria

Inclusion Criteria:

- Use of cannabis at least once a week confirmed by urine point-of-care testing;

- Males who report consuming at least 5 drinks and females who report consuming at least
4 drinks in about 2 hours in the past 6 months and at least one episode of rapid
alcohol consumption in the past 6 months (3 or more drinks over a span of one hour)

- 19-29 years of age;

- Holds a class G or G2 Ontario driver's licence (or equivalent from another
jurisdiction) for at least 12 months;

- Willing to abstain from using alcohol for 48 hours and cannabis for 72 hours prior to
Practice and Test Sessions.

- Willing to abstain from all other drugs not prescribed for medical purposes for the
duration of the study;

- Provides written and informed consent.

Exclusion Criteria:

- Urine toxicology screens negative for cannabis upon eligibility assessment;

- Diagnosis of severe medical or psychiatric conditions;

- Females: Pregnancy or breastfeeding;

- Meets criteria for Alcohol or Substance Dependence (current or lifetime) (DSM-IV);

- Is a regular user of medications that affect brain function (i.e., antidepressants,
benzodiazepines, stimulants);

- Taking medications or have any medical condition for which alcohol is contraindicated;

- First-degree relative diagnosed with schizophrenia;

- Severe allergy to citrus (lemon-lime).



Age minimum: 19 Years
Age maximum: 29 Years
Gender: All

Health Condition(s) or Problem(s) studied

Psychomotor Impairment

Intervention(s)

Drug: Placebo alcohol

Drug: Alcohol

Drug: placebo delta 9 tetrahydrocannabinol

Drug: delta 9 tetrahydrocannabinol

Primary Outcome(s)

Psychomotor impairment: Standard deviation of lateral position [Time Frame: Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Driving simulation tests occur within 2 hours before and approximately 45 minutes after Time 0.]

Secondary Outcome(s)

Urine cannabinoids corrected for creatinine [Time Frame: Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Ratio of excreted THC metabolite carboxy-THC to creatinine is assessed within 2 hours before Time 0 as well as approximately 5 hours after Time 0.]

Psychomotor impairment: Minimum time to collision and brake latency [Time Frame: Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Driving simulation tests occur within 2 hours before and approximately 45 minutes after Time 0.]

Psychomotor impairment: Mean speed, standard deviation of speed, and maximum speed [Time Frame: Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Driving simulation tests occur within 2 hours before and approximately 45 minutes after Time 0.]

Vital signs: blood pressure [Time Frame: Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Vital signs are assessed within 2 hours before as well as approximately 15, 30, 45, and 75 minutes and 2, 3, 4, and 5 hours after Time 0.]

Subjective alcohol and cannabis effects [Time Frame: Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Visual analogue scales are administered within 2 hours before as well as approximately 15, 30, 45, and 75 minutes and 2, 3, 4, and 5 hours after Time 0.]

Vital signs: pulse [Time Frame: Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Vital signs are assessed within 2 hours before as well as approximately 15, 30, 45, and 75 minutes and 2, 3, 4, and 5 hours after Time 0.]

Vital signs: temperature [Time Frame: Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Vital signs are assessed within 2 hours before as well as approximately 15, 30, 45, and 75 minutes and 2, 3, 4, and 5 hours after Time 0.]

Breath alcohol content [Time Frame: Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Breath alcohol content is measured within 2 hours before Time 0 as well as approximately 15, 30, 45, and 75 minutes and 2, 3, 4, and 5 hours after Time 0.]

Vital signs: respiration [Time Frame: Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Vital signs are assessed within 2 hours before as well as approximately 15, 30, 45, and 75 minutes and 2, 3, 4, and 5 hours after Time 0.]

Blood concentration for delta 9 tetrahydrocannabinol, carboxy-tetrahydrocannabinol, and 11 hydroxy tetrahydrocannabinol. [Time Frame: Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Blood concentration for THC, THC-COOH, and 11-OH-THC is assessed within 2 hours before Time 0 as well approximately 45 minutes after Time 0.]

Cognitive testing [Time Frame: Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Cognitive testing is administered within 2 hours before Time 0 as well as approximately 75 minutes after Time 0.]

Psychomotor impairment: Number of collisions [Time Frame: Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Driving simulation tests occur within 2 hours before and approximately 45 minutes after Time 0.]

Secondary ID(s)

123-2015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Canadian Institutes of Health Research (CIHR)

Health Canada