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| ID | Type | Description | Link |
|---|---|---|---|
| R21DA045101-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This study will examine the effects of various strains of marijuana on simulated driving performance; the effects of alcohol administration will also be examined to further understand how marijuana-induced driving changes compare to the effects of alcohol. Secondary outcomes will include physiological effects, subjective- and observer-rated outcomes, and psychomotor performance under the various dose conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Marijuana Dose | Experimental | Participants will receive experimental/non-therapeutic dose(s) of active marijuana, under double-blind conditions |
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| Inactive Marijuana Dose | Placebo Comparator | Participants will receive experimental/non-therapeutic dose(s) of inactive marijuana, under double-blind conditions |
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| Active Alcohol Dose | Active Comparator | Participants will receive experimental/non-therapeutic dose(s) of active alcohol, under double-blind conditions |
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| Inactive Alcohol Dose | Placebo Comparator | Participants will receive experimental/non-therapeutic dose(s) of inactive alcohol, under double-blind conditions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Marijuana | Drug | Experimental, non-therapeutic administration of active marijuana dose(s) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Peak for Standard Deviation in Lane Position (SDLP) | Standard deviation of lane position (SDLP) of the car is the amount of weaving/swerving of the car in and out of the lane. It is a frequent metric for assessing driving ability. | This outcome was recorded in regular intervals after drug administration for the duration of the session (approx. 9 hrs) and a peak score was calculated across all these time intervals. |
| Measure | Description | Time Frame |
|---|---|---|
| Subject-Rated Outcomes: Mean Peak Score for Driving Difficulty | Participants rated their subjective response on a standardized VAS scale (0 to 100). Higher scores indicate worse outcome/greater impairment. Raw data transformed to peak scores. | This outcome (VAS score) was recorded in regular intervals after drug administration for the duration of the session (approx. 9 hrs) and a peak score was calculated across all these time intervals. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40508 | United States |
There are no plans to share individual participant data with other outside researchers.
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Participants meeting all I/E criteria were invited to enroll. Unique, randomized dose orders were created for each participant. The study utilized a within-subject, randomized, placebo-controlled, double-dummy, double-blind design.
Participants were recruited via internet postings (e.g., Craigslist) and locally posted flyers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Marijuana Effects on Simulated Driving Performance | Within subject study. Participants will receive experimental/non-therapeutic doses of active/inactive marijuana in combination experimental/non-therapeutic dose of inactive/active alcohol. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Completing Participants | Subjects who completed the study |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Peak for Standard Deviation in Lane Position (SDLP) | Standard deviation of lane position (SDLP) of the car is the amount of weaving/swerving of the car in and out of the lane. It is a frequent metric for assessing driving ability. | Per Protocol population, defined as participants completing the experimental drug conditions. | Posted | Mean | Standard Error | centimeters | This outcome was recorded in regular intervals after drug administration for the duration of the session (approx. 9 hrs) and a peak score was calculated across all these time intervals. |
|
4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Inactive Alcohol / THC 0mgPerformance | Participants will receive experimental/non-therapeutic dose of inactive alcohol, under double-blind conditions Participants will receive experimental/non-therapeutic dose of inactive marijuana, under double-blind conditions |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| stomachache | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shanna Babalonis, Ph.D. | University of Kentucky | 859-257-1881 | babalonis@uky.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Dec 26, 2023 | Apr 29, 2024 | Prot_ICF_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 26, 2023 | May 24, 2024 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D004327 | Drinking Behavior |
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| ID | Term |
|---|---|
| C587251 | nabiximols |
| D000431 | Ethanol |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D009043 | Motor Activity |
| D009068 | Movement |
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Within-subject, randomized, placebo-controlled, double-dummy, double-blind study
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Double-blind, double-dummy, placebo-controlled design
| Alcohol | Drug | Experimental, non-therapeutic administration of active alcohol dose(s) |
|
|
| placebo alcohol | Drug | Experimental, non-therapeutic administration of inactive alcohol dose(s) |
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| Inactive marijuana | Drug | Experimental, non-therapeutic administration of inactive marijuana dose(s) |
|
|
| Subject-Rated Outcome: Mean Peak Score for Drug and Alcohol Effect | Participants rated their subjective response on a standardized VAS scale (0 to 100). Higher scores indicate greater drug effects. Raw data transformed to peak scores. | This outcome (VAS scores) was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 9 hrs) |
| Subject-Rated Outcome: Mean Peak Score for Difficulty Concentrating | Participants rated their subjective response on a Likert type scale (Not at all=0, A Little Bit=1, Moderately=2, Quite A Bit=3, Extremely=4). Greater values indicate greater drug effect. Raw data transformed to peak scores. | This outcome was recorded in regular intervals after drug administration for the duration of the session (approx. 9 hrs) and a peak score was calculated across all these time intervals. |
| Observer-Rated Outcome: Mean Peak Score for Relaxed | Research observer rated on a Likert type scale (Not at all=0, A Little Bit=1, Moderately=2, Quite A Bit=3, Extremely=4). Greater values indicate greater drug effect. Raw data transformed to peak scores. | This outcome was recorded in regular intervals after drug administration for the duration of the session (approx. 9 hrs) and a peak score was calculated across all these time intervals. |
| Observer-Rated Outcome: Mean Peak Score for Good Mood | Research observer rated on a Likert type scale (Not at all=0, A Little Bit=1, Moderately=2, Quite A Bit=3, Extremely=4). Greater values indicate greater drug effect. Raw data transformed to peak scores. | This outcome was recorded in regular intervals after drug administration for the duration of the session (approx. 9 hrs) and a peak score was calculated across all these time intervals. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | Inactive Alcohol / THC 15mg | Participants will receive experimental/non-therapeutic dose of inactive alcohol, under double-blind conditions Participants will receive experimental/non-therapeutic dose of active marijuana, under double-blind conditions |
| OG002 | Inactive Alcohol / THC 30mg | Participants will receive experimental/non-therapeutic dose of inactive alcohol, under double-blind conditions Participants will receive experimental/non-therapeutic dose of active marijuana, under double-blind conditions |
| OG003 | Inactive Alcohol / Combined THC 15mg / CBD 7.5mg | Participants will receive experimental/non-therapeutic dose of inactive alcohol, under double-blind conditions Participants will receive a combined experimental/non-therapeutic dose of active marijuana and Cannabidiol (CBD), under double-blind conditions |
| OG004 | Active Alcohol / THC 0mg | Participants will receive experimental/non-therapeutic dose of active alcohol, under double-blind conditions Participants will receive experimental/non-therapeutic dose of inactive marijuana, under double-blind conditions |
|
|
| Secondary | Subject-Rated Outcomes: Mean Peak Score for Driving Difficulty | Participants rated their subjective response on a standardized VAS scale (0 to 100). Higher scores indicate worse outcome/greater impairment. Raw data transformed to peak scores. | Per Protocol population, defined as participants completing the experimental drug conditions. | Posted | Mean | Standard Error | Score on a scale (0 to 100) | This outcome (VAS score) was recorded in regular intervals after drug administration for the duration of the session (approx. 9 hrs) and a peak score was calculated across all these time intervals. |
|
|
|
| Secondary | Subject-Rated Outcome: Mean Peak Score for Drug and Alcohol Effect | Participants rated their subjective response on a standardized VAS scale (0 to 100). Higher scores indicate greater drug effects. Raw data transformed to peak scores. | Per Protocol population, defined as participants completing the experimental drug conditions. | Posted | Mean | Standard Error | Score on a scale (0 to 100) | This outcome (VAS scores) was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 9 hrs) |
|
|
|
| Secondary | Subject-Rated Outcome: Mean Peak Score for Difficulty Concentrating | Participants rated their subjective response on a Likert type scale (Not at all=0, A Little Bit=1, Moderately=2, Quite A Bit=3, Extremely=4). Greater values indicate greater drug effect. Raw data transformed to peak scores. | Per Protocol population, defined as participants completing the experimental drug conditions. | Posted | Mean | Standard Error | Score on a scale (0 to 4) | This outcome was recorded in regular intervals after drug administration for the duration of the session (approx. 9 hrs) and a peak score was calculated across all these time intervals. |
|
|
|
| Secondary | Observer-Rated Outcome: Mean Peak Score for Relaxed | Research observer rated on a Likert type scale (Not at all=0, A Little Bit=1, Moderately=2, Quite A Bit=3, Extremely=4). Greater values indicate greater drug effect. Raw data transformed to peak scores. | Per Protocol population, defined as participants completing the experimental drug conditions. | Posted | Mean | Standard Error | Score on a scale (0 to 4) | This outcome was recorded in regular intervals after drug administration for the duration of the session (approx. 9 hrs) and a peak score was calculated across all these time intervals. |
|
|
|
| Secondary | Observer-Rated Outcome: Mean Peak Score for Good Mood | Research observer rated on a Likert type scale (Not at all=0, A Little Bit=1, Moderately=2, Quite A Bit=3, Extremely=4). Greater values indicate greater drug effect. Raw data transformed to peak scores. | Per Protocol population, defined as participants completing the experimental drug conditions. | Posted | Mean | Standard Error | Score on a scale (0 to 4) | This outcome was recorded in regular intervals after drug administration for the duration of the session (approx. 9 hrs) and a peak score was calculated across all these time intervals. |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 1 |
| 9 |
| EG001 | Inactive Alcohol / THC 15mg | Participants will receive experimental/non-therapeutic dose of inactive alcohol, under double-blind conditions Participants will receive experimental/non-therapeutic dose of active marijuana, under double-blind conditions | 0 | 9 | 0 | 9 | 1 | 9 |
| EG002 | Inactive Alcohol / THC 30mg | Participants will receive experimental/non-therapeutic dose of inactive alcohol, under double-blind conditions Participants will receive experimental/non-therapeutic dose of active marijuana, under double-blind conditions | 0 | 9 | 0 | 9 | 2 | 9 |
| EG003 | Inactive Alcohol / Combined THC 15mg / CBD 7.5mg | Participants will receive experimental/non-therapeutic dose of inactive alcohol, under double-blind conditions Participants will receive a combined experimental/non-therapeutic dose of active marijuana and CBD, under double-blind conditions | 0 | 9 | 0 | 9 | 1 | 9 |
| EG004 | Active Alcohol / THC 0mg | Participants will receive experimental/non-therapeutic dose of active alcohol, under double-blind conditions Participants will receive experimental/non-therapeutic dose of inactive marijuana, under double-blind conditions | 0 | 9 | 0 | 9 | 3 | 9 |
| Nausea/Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Chills | Nervous system disorders | Systematic Assessment |
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| Muscle/limb pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Upper respiratory infection | Infections and infestations | Systematic Assessment |
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| D001519 | Behavior |
| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |