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| Name | Class |
|---|---|
| Ontario Ministry of Transportation | UNKNOWN |
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Given the known driving behavior of Driving Under the Influence of Alcohol and some of its parallel to driving under the influence of cannabis, this supplemental study aims to validate the sensitivity of the primary and secondary outcome measures employed in a cannabis and driving study currently in progress.
This study will examine the effects of an intoxicating dose of alcohol on driving-related skills among young drivers using driving simulator technology.
This study is a double-blind, placebo-controlled mixed design study, including randomized between-subjects comparison of the effects of alcohol intoxication and both between- and within-subjects examination of acute and residual effects at approximately 24 and 48 hours following one-time alcohol administration.
Initial contact with potential participants will be made by telephone, where study personnel will conduct a telephone screen for eligibility. Those telephone screened as eligible will attend CAMH for an eligibility assessment. Enrolled participants will complete four sessions on consecutive days: a practice day, an alcohol administration day, and a 24-hour and 48-hour post-alcohol session.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alcohol | Active Comparator | Alcohol |
|
| Placebo | Placebo Comparator | Tonic water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alcohol | Drug | A single oral administration of an alcoholic beverage mixed in a 1:3 ratio of alcohol (Vodka) to tonic water to obtain a target BAC of 0.08mg% |
|
| Measure | Description | Time Frame |
|---|---|---|
| Psychomotor impairment (driving) | The driving simulator will objectively measure changes in driving behaviour after drinking alcohol. | Approximate Time Frame: 30 minutes before, 30 minutes after, 24 and 48 hours after drinking |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective alcohol effects | Visual analogue scale measures how participants feel before and after drinking alcohol. administration. | Approximate Time Frame: 30 minutes before drinking, 5, 15, 30 minutes and 1, 2, 3, 24 and 48 hours post-drinking |
| Cognitive testing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Mann, PhD | Centre for Addiction and Mental Health | Principal Investigator |
| Bernard Le Foll, MD, PhD | Centre for Addiction and Mental Health | Principal Investigator |
| Bruna Brands, PhD | Centre for Addiction and Mental Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Addiction and Mental Health | Toronto | Ontario | M5S 2S1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20380913 | Background | Lenne MG, Dietze PM, Triggs TJ, Walmsley S, Murphy B, Redman JR. The effects of cannabis and alcohol on simulated arterial driving: Influences of driving experience and task demand. Accid Anal Prev. 2010 May;42(3):859-66. doi: 10.1016/j.aap.2009.04.021. |
| Label | URL |
|---|---|
| The Centre for Addiction and Mental Health (CAMH) is the leading mental health and addictions research facility in Canada, and one of the largest in the world. | View source |
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| ID | Term |
|---|---|
| D011596 | Psychomotor Disorders |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| Placebo | Drug | A single oral administration of a beverage containing tonic water of the same volume as the alcoholic beverage. |
|
|
Changes in Continuous Performance Test performance. |
| Approximate Time Frame: 30 minutes before drinking, and 1, 24 and 48 hours post-drinking |
| Breath alcohol content (BAC) | Changes in BAC after drinking | Approximate Time Frame: 30 minutes before drinking, 5, 15, 30, minutes and 1, 2, 3, 24, and 48 hours post-drinking |
| D013568 | Pathological Conditions, Signs and Symptoms |