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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA059584 | 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 evaluate the subjective and behavioral effects of cannabis products labeled as indica, sativa, or generic.
This clinical laboratory study will be double-blind, placebo-controlled and will utilize a within-subjects experimental design. Participants will complete 6 outpatient drug administration sessions that will consist of self-administration of smoked cannabis (0, or 25mg THC) labeled as indica, sativa, or generically-labelled. Primary outcomes include performance on cognitive and psychomotor assessments, subjective drug effects, and simulated driving performance. Smoking topography will also be characterized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indica-Labeled Cannabis - Placebo | Placebo Comparator | Participants administer smoked cannabis labeled as indica containing 0mg THC. |
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| Sativa-Labeled Cannabis - Placebo | Placebo Comparator | Participants administer smoked cannabis labeled as Sativa containing 0mg THC. |
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| Generically-Labeled Cannabis - Placebo | Placebo Comparator | Participants administer smoked cannabis labeled generically containing 0mg THC. |
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| Indica-Labeled Cannabis - Active | Experimental | Participants administer smoked cannabis labeled as indica containing 25mg THC. |
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| Sativa-Labeled Cannabis - Active | Experimental | Participants administer smoked cannabis labeled as sativa containing 25mg THC. |
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| Generically-Labeled Cannabis - Active |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabis | Drug | Cannabis will be administered via smoked inhalation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Correct Trials on Paced Auditory Serial Addition Task (PASAT) | Computerized version of Paced Auditory Serial Addition Task will be administered to assess working memory performance. Will report the total correct trials out of 90 recorded (lower scores indicate worse performance). | Baseline, 0-, 1-, 1.5-, 2-, 3-, 4-, 5-, and 6-hours post-dosing |
| Driving Under the Influence of Drugs (DRUID) application global impairment score | Acute cognitive and behavioral impairment will be assessed with global impairment score(range 0-100) on the DRUID app (higher scores indicate greater impairment). | Baseline, 0-, 1-, 1.5-, 2-, 3-, 4-, 5-, and 6-hours post-dosing |
| Number of Correct Trials on the Digit Symbol Substitution Task (DSST) | Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. Will report the total correct trials in 90 seconds (lower scores indicate worse performance). | Baseline, 0-, 1-, 1.5-, 2-, 3-, 4-, 5-, and 6-hours post-dosing |
| Biphasic alcohol effects scale (BAES) - Sedative Score | The BAES is used to assess sedative and stimulant subjective effects of alcohol. It has been shown to be sensitive to the effects of cannabis too. There are 7 sedative-related questionnaire items, each presented on a scale of 0 (not at all) to 10 (extremely), which are integrated to produce an overall sedative score (0-70). Higher score more effects. | Baseline, 0-, 0.5-, 1-, 1.5-, 2-, 3-, 4-, 5-, and 6-hours post-dosing |
| Biphasic alcohol effects scale (BAES) - Stimulant Score | The BAES is used to assess sedative and stimulant subjective effects of alcohol. It has been shown to be sensitive to the effects of cannabis too. There are 7 stimulant-related questionnaire items, each presented on a scale of 0 (not at all) to 10 (extremely), which are integrated to produce an overall stimulant score (0-70). Higher score more effects. |
| Measure | Description | Time Frame |
|---|---|---|
| Drug Effect Questionnaire - Like Drug Effect | The DEQ will be used to obtain subjective ratings of "like drug effect". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation. | Baseline, 0-, 0.5-, 1-, 1.5-, 2-, 3-, 4-, 5-, and 6-hours post-dosing |
| Anticipated Effects of Cannabis Scale (AECS) - Creative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carlos A Zamarripa, PhD | Contact | 410-550-6969 | czamarr2@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Carlos A Zamarripa, PhD | Johns Hopkins University | Principal Investigator |
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| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C587251 | nabiximols |
| D013759 | Dronabinol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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All participants will complete all dose conditions (study arms) in a randomized order
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| Experimental |
Participants administer smoked cannabis labeled generically containing 25mg THC. |
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| 0 mg THC (placebo) | Other | 0 mg THC (placebo) |
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| Baseline, 0-, 0.5-, 1-, 1.5-, 2-, 3-, 4-, 5-, and 6-hours post-dosing |
| Driving performance as assessed by standard deviation of lateral position (SDLP) | The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions. SDLP (measured in cm) will be determined during each drive. This measure is a composite index of lateral control and incorporates lane weaving, swerving, and over-correcting. SDLP is the gold standard of quantifying the magnitude of driving impairment from drugs and alcohol and has excellent predictive validity to actual driving. Scores range from 0 to no upper limit. Higher scores represent higher magnitude of driving impairment. | Baseline, 0-, 2-, 4-, and 6-hours post dosing. |
| Driving performance as assessed by global drive score | Driving impairment will be assessed via a composite drive score (higher scores indicate greater impairment). The composite drive score is derived by integrating various driving outcomes (see primary and secondary driving outcomes). There is no upper or lower limit to possible scores | Baseline, 0-, 2-, 4-, and 6-hours post dosing. |
| Drug Effect Questionnaire (DEQ) - Feel Drug Effect | The DEQ will be used to obtain subjective ratings of "feel drug effects". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation. | Baseline, 0-, 0.5-, 1-, 1.5-, 2-, 3-, 4-, 5-, and 6-hours post-dosing |
| Drug Effect Questionnaire - Confidence to Drive | The DEQ will be used to obtain subjective ratings of "confidence to drive". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation. | Baseline, 0-, 0.5-, 1-, 1.5-, 2-, 3-, 4-, 5-, and 6-hours post-dosing |
| Drug Effect Questionnaire - Alert | The DEQ will be used to obtain subjective ratings of "alert". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation. | Baseline, 0-, 0.5-, 1-, 1.5-, 2-, 3-, 4-, 5-, and 6-hours post-dosing |
| Drug Effect Questionnaire - Sleepy/Tired | The DEQ will be used to obtain subjective ratings of "sleepy/tired". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation. | Baseline, 0-, 0.5-, 1-, 1.5-, 2-, 3-, 4-, 5-, and 6-hours post-dosing |
The AECS will be used to obtain subjective ratings of "creative". Score range from 0 (none) to 10 (extreme) using a 10mm line anchored with none/extreme designation. |
| Baseline prior to drug administration |
| Anticipated Effects of Cannabis Scale (AECS) - Drowsy | The AECS will be used to obtain subjective ratings of "Drowsy". Score range from 0 (none) to 10 (extreme) using a 10mm line anchored with none/extreme designation. | Baseline prior to drug administration |