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Trial record 41 of 170 for:    cannabis | Recruiting, Enrolling by invitation Studies

Combined Alcohol and Cannabis Effects on Skills of Young Drivers

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ClinicalTrials.gov Identifier: NCT03106363
Recruitment Status : Recruiting
First Posted : April 10, 2017
Last Update Posted : January 9, 2018
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Health Canada
Information provided by (Responsible Party):
Christine Wickens, Centre for Addiction and Mental Health

Brief Summary:
Alcohol and cannabis are the two most widely used substances of abuse in the world and are the psychoactive substances most often found in seriously and fatally injured drivers. In a recent study, it was observed that individuals who reported both driving under the influence of alcohol (DUIA) and the influence of cannabis (DUIC) experienced collision risk that was nearly 4 times that of individuals who reported driving after using only one of these drugs. Recent research in the United States and Canada indicates that the prevalence of DUIC among young drivers of high school and university age, and young adults is similar to, or higher than, the prevalence of DUIA. This is a serious public health issue, since motor vehicle collisions are the leading cause of death in this age group. Given the frequency with which alcohol and cannabis are consumed together, it is important to understand their combined effects on driver behaviour. The residual or 'hangover' effects of these substances on road safety are also not well understood, but may be substantial. To date, the residual effects of combined use have not been examined. The current study will examine the acute and residual effects of a moderate dose of cannabis (12.5% THC) combined with an intoxicating amount of alcohol (BAC=0.08) on driving simulator performance of young drivers. Following an eligibility screening and practice session, a total of 70 participants aged 19 to 25 years will each complete 8 experimental sessions (2 sessions/week). During the first session of each week, subjects will drink alcohol or placebo alcohol and smoke an active or placebo cannabis cigarette. The effects of alcohol and cannabis on the performance of driving-related skills will be assessed using a high-fidelity driving simulator. Cognitive, psychomotor, and mood effects will also be assessed. Twenty-four hours after alcohol/drug exposure, subjects will attend the second session of the week where driving-related, cognitive, psychomotor, and mood effects will be assessed again.

Condition or disease Intervention/treatment Phase
Psychomotor Impairment Drug: delta 9 tetrahydrocannabinol Drug: placebo delta 9 tetrahydrocannabinol Drug: Alcohol Drug: Placebo alcohol Early Phase 1

Detailed Description:

The proposed study will pursue the following primary aims:

Aim 1: Examine the residual effects of a moderate dose of cannabis (12.5% THC) combined with an intoxicating amount of alcohol (BAC=0.08) on driving simulator performance of young drivers. Simulated driving performance, tests of cognition, verbal memory, and mood will be measured concurrently with levels of cannabinoids and alcohol metabolites in biological fluids at approximately 24 hours following acute drug exposure in male and female drivers aged 19 to 25.

Aim 2: Examine the acute effects of a moderate dose of cannabis (12.5% THC) combined with an intoxicating amount of alcohol (BAC=0.08) on driving simulator performance of young drivers. Simulated driving performance, tests of cognition, verbal memory, and mood will be measured concurrently with BAC and levels of cannabinoids in biological fluids before and after acute drug exposure in male and female drivers aged 19 to 25. BAC and biological fluids will be measured up to 5 hours following drug exposure.

Aim 3: Explore the effects of driving history, driving attitudes, and individual difference measures (e.g., demographics, drug and alcohol use, etc.) on the acute and residual effects of alcohol and cannabis on driving simulator performance of young drivers. Exploratory analyses will be undertaken to determine if the acute and residual effects of cannabis plus alcohol on the driving simulator task are influenced by these measures.

Study Design and Duration

This study will be a within-subjects, double-blind, double-dummy, placebo-controlled, counterbalanced, randomized clinical trial assessing the impact of alcohol and cannabis combined on driver behaviour. Although a placebo condition is part of the study, this is not a treatment study.

Initial contact with potential subjects will be made via telephone, and study personnel will conduct a telephone screen for eligibility. Upon eligibility confirmation by telephone, participants will be asked to attend CAMH for an eligibility assessment. Subjects will attend CAMH for a total of 10 study sessions (an eligibility assessment, a practice day, and 8 testing days).

Participants will come to the lab for four testing weeks (Sessions 1-8) comprising two sessions each week. Each week participants will undergo one of these alcohol and cannabis exposure conditions: 1) placebo alcohol and placebo cannabis; 2) intoxicating dose of alcohol and placebo cannabis; 3) placebo alcohol and active cannabis, and; 4) intoxicating dose of alcohol and active cannabis. The order of these conditions will be randomly assigned. Each week the first session will be a session where participants will complete an alcohol manipulation followed by a cannabis manipulation (Sessions 1, 3, 5 and 7). Each week a second session will be completed approximately 24 hours after the alcohol and cannabis exposure session to measure residual effects (Sessions 2, 4, 6 and 8). The alcohol and cannabis exposure sessions will be separated by 7-15 days.

Participants will be asked not to use cannabis for 72 hours and alcohol for 48 hours prior to attending CAMH.

In certain instances, the Qualified Investigator may ask a participant to return for re-screening, e.g. repeat of urine test or other assessments performed for eligibility assessment. Also, in case of unforeseen delays in scheduling study participation, the Qualified Investigator will determine if there is a need to ask a participant to repeat some assessments, e.g., physical examination.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Effects of Combined Alcohol and Cannabis on Young Drivers' Simulated Driving
Actual Study Start Date : July 4, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Active Comparator: Alcohol/Placebo Cannabis
Participant will drink an alcoholic beverage to obtain a target blood alcohol content of 0.08mg% and will smoke a placebo delta 9 tetrahydrocannabinol (< 0.03%) cigarette.
Drug: placebo delta 9 tetrahydrocannabinol
A single placebo cannabis cigarette (<0.03% delta 9 tetrahydrocannabinol) will be given to participants to smoke over a 10 minute period, ad libitum. If the placebo cannabis cigarette is not smoked in its entirety, the remainder will be weighed to estimate dose (as this is a double-blind study).
Other Names:
  • cannabis sativa
  • marijuana

Drug: Alcohol
A single oral administration of an alcoholic beverage mixed in a 1:3 ratio of alcohol to tonic water to obtain a target blood alcohol content of 0.08mg%.
Other Name: ethanol

Active Comparator: Placebo Alcohol/Cannabis
Participant will drink tonic water (capped with a minimal amount of alcohol to enhance alcohol cues) and will smoke a delta 9 tetrahydrocannabinol (potency 12.5%) cigarette.
Drug: delta 9 tetrahydrocannabinol
A single cannabis cigarette (potency 12.5% delta 9 tetrahydrocannabinol) will be given to participants to smoke over a 10 minute period, ad libitum. If the cannabis cigarette is not smoked in its entirety, the remainder will be weighed to estimate dose.
Other Names:
  • cannabis sativa
  • marijuana

Drug: Placebo alcohol
A single oral administration of a beverage containing tonic water of the same volume as the alcoholic beverage.
Other Name: Tonic water

Active Comparator: Alcohol/Cannabis
Participant will drink an alcoholic beverage to obtain a target blood alcohol content of 0.08mg% and will smoke a delta 9 tetrahydrocannabinol (potency 12.5%) cigarette.
Drug: delta 9 tetrahydrocannabinol
A single cannabis cigarette (potency 12.5% delta 9 tetrahydrocannabinol) will be given to participants to smoke over a 10 minute period, ad libitum. If the cannabis cigarette is not smoked in its entirety, the remainder will be weighed to estimate dose.
Other Names:
  • cannabis sativa
  • marijuana

Drug: Alcohol
A single oral administration of an alcoholic beverage mixed in a 1:3 ratio of alcohol to tonic water to obtain a target blood alcohol content of 0.08mg%.
Other Name: ethanol

Placebo Comparator: Placebo Alcohol/Placebo Cannabis
Participant will drink tonic water (capped with a minimal amount of alcohol to enhance alcohol cues) and will smoke a placebo delta 9 tetrahydrocannabinol (< 0.03%) cigarette.
Drug: placebo delta 9 tetrahydrocannabinol
A single placebo cannabis cigarette (<0.03% delta 9 tetrahydrocannabinol) will be given to participants to smoke over a 10 minute period, ad libitum. If the placebo cannabis cigarette is not smoked in its entirety, the remainder will be weighed to estimate dose (as this is a double-blind study).
Other Names:
  • cannabis sativa
  • marijuana

Drug: Placebo alcohol
A single oral administration of a beverage containing tonic water of the same volume as the alcoholic beverage.
Other Name: Tonic water




Primary Outcome Measures :
  1. Psychomotor impairment [ Time Frame: Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Driving simulation tests occur 30 minutes before, 30 minutes after, and 24 hours after Time 0. ]
    The driving simulator will objectively measure changes in driving behavior after alcohol and/or cannabis exposure.


Secondary Outcome Measures :
  1. Subjective drug effects [ Time Frame: Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Visual analogue scales are administered 2 hours before as well as 15, 30, 45, and 75 minutes and 2, 3, 4, 5, and 24 hours after Time 0. ]
    Visual analogue scale measures how participants feel before and after alcohol and/or cannabis exposure.

  2. Neuro-cognitive testing [ Time Frame: Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Neuro-cognitive testing is administered 2 hours before Time 0 as well as 75 minutes and 24 hours after Time 0. ]
    Measures changes in performance related to attention, memory, field of view, and dexterity before and after alcohol and/or cannabis exposure.

  3. Breath alcohol content [ Time Frame: Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Breath alcohol content is measured 2 hours before Time 0 as well as 15, 30, 45, and 75 minutes and 2, 3, 4, 5, and 24 hours after Time 0. ]
    Changes in BAC after drinking alcohol.

  4. 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 2 hours before Time 0 as well 30 minutes and 24 hours after Time 0. ]
    Changes in concentration of delta 9 tetrahydrocannabinol (THC) , carboxy-tetrahydrocannabinol (THC-COOH), and 11 hydroxy tetrahydrocannabinol (11-OH-THC) in blood.

  5. 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 2 hours before Time 0 as well as 5 and 24 hours after Time 0. ]
    Determination of the ratio of excreted THC metabolite carboxy-THC to creatinine will determine whether participants have used cannabis between testing days, and hence will be excluded from further participation.

  6. Blood concentration for ethylglucuronide and ethylsulphate [ Time Frame: Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Blood concentration for ethylglucuronide and ethylsulphate is assessed 2 hours before Time 0 and 24 hours after Time 0. ]
    Concentration of alcohol metabolites ethylglucuronide and ethylsulphate in blood will determine if participants have used alcohol between testing days, and hence will have their data excluded from the final analysis.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Weekly use of cannabis (1 to 4 days per 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 on at least one occasion 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)
  • 19-25 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 (Sessions 1, 3, 5 and 7) up until each 24-hour post-drug administration session (Sessions 2, 4, 6 and 8).
  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03106363


Contacts
Contact: Bruna Brands, PhD 416-535-8501 ext 36860 bruna.brands@camh.ca

Locations
Canada, Ontario
Centre for Addiction and Mental Health Recruiting
Toronto, Ontario, Canada, M5S 2S1
Contact: Bruna Brands, PhD    416-535-8501 ext 36860    bruna.brands@camh.ca   
Sponsors and Collaborators
Centre for Addiction and Mental Health
Canadian Institutes of Health Research (CIHR)
Health Canada
Investigators
Principal Investigator: Christine M Wickens, PhD Centre for Addiction and Mental Health

Additional Information:
Publications:
Responsible Party: Christine Wickens, Independent Scientist, Institute for Mental Health Policy Research, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT03106363     History of Changes
Other Study ID Numbers: 123-2015
First Posted: April 10, 2017    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Psychomotor Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Ethanol
Dronabinol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Hallucinogens
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists