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cancellation of funding contract
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This study will evaluate physiological and behavioral responses to vaporized delta9-Tetrahydrocannabinol (THC) and cannabidiol (CBD) administered via inhalation.
The proposed study will be conducted at the Johns Hopkins Behavioral Pharmacology Research Unit (BPRU). In this between-subjects study, participants will be randomized to complete 1 of 8 possible acute drug administration sessions in which participants will administer THC alone, CBD alone, THC and CBD together, or placebo. Following drug administration, participants will complete a performance session and complete a battery of questionnaires assessing subjective drug effects, mood, affect, and mental state. Vital signs and hormone levels will also be assessed before and after drug administration. The study will help the investigators understand the individual and interactive effects of THC and CBD, the two most common cannabis constituents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Distilled Water |
|
| Vaporized THC alone | Experimental | 5mg pure THC |
|
| Vaporized low CBD alone | Experimental | 50mg pure CBD |
|
| Vaporized medium CBD alone | Experimental | 100mg pure CBD |
|
| Vaporized high CBD alone | Experimental | 200mg pure CBD |
|
| Vaporized low CBD with THC | Experimental | 50mg pure CBD paired with 5mg THC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo vapor (distilled water) |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood cortisol levels | Peak change in blood cortisol levels in micrograms per deciliter (ug/dl) will be measured | Prior to drug exposure and for 4 hours post-exposure. |
| Change in blood Adrenocorticotropic hormone (ACTH) levels | Peak change in blood ACTH levels in picograms per milliliter (pg/ml) will be measured | Prior to drug exposure and for 4 hours post-exposure. |
| Change in heart rate | Peak change in rate (in beats per minute) | Prior to drug exposure and for 4 hours post-exposure. |
| Change in State Anxiety levels as assessed by the State-Trait Anxiety Inventory (STAI) | Peak change in composite STAI score. Scale consists of 20 items assessing state anxiety levels; each item is on 4 point Likert scale ranging from 1 (not at all) to 4 (almost always). Items are summed to obtain a composite score which can range from 20 to 80 (higher scores indicate more anxiety). | Prior to drug exposure and for 4 hours post-exposure. |
| Change in Mood state as assessed by the The Profile of Mood States (POMS) | Peak change in total tension-anxiety sub-scale score for POMS. This sub-scale of the POMS consists of 9 items, each on a 4-point Likert scale ranging from 1 (not at all) to 4 (extremely) which are summed to create a total score of 9 to 36 (higher scores indicate more tension/anxiety). | Prior to drug exposure and for 4 hours post-exposure. |
| Change in Positive affect levels as assessed by The Positive and Negative Affect Schedule (PANAS) | Peak change in total positive affect score. This PANAS consists of 20 items assessing positive affect (10 items) and negative affect (10 items). Each item is on a 5-point Likert scale ranging from 1 (very slightly or not at all) to 5 (extremely). 10 positive affect items are summed to create a total positive affect score while the 10 negative affect items are summed to create a total negative affect score; higher total scores indicate more positive affect or more negative (i.e., worse) affect. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elise Weerts, PhD | Johns Hopkins University | Principal Investigator |
| Ryan Vandrey, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Behavioral Pharmacology Research Unit | Baltimore | Maryland | 21224 | United States |
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| ID | Term |
|---|---|
| D013759 | Dronabinol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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placebo controlled, double-blind
| Vaporized medium CBD with THC |
| Experimental |
100mg pure CBD paired with 5mg THC |
|
| Vaporized high CBD with THC | Experimental | 200mg pure CBD paired with 5mg THC |
|
| Vaporized THC alone | Drug | Acute exposure to vaporized THC |
|
| Vaporized CBD alone | Drug | Acute exposure to vaporized CBD |
|
| Vaporized CBD with THC | Drug | Acute exposure to vaporized CBD with THC |
|
| Prior to drug exposure and for 4 hours post-exposure. |
| Change in Negative affect levels as assessed by The Positive and Negative Affect Schedule (PANAS) | Peak change in total negative affect score. This PANAS consists of 20 items assessing positive affect (10 items) and negative affect (10 items). Each item is on a 5-point Likert scale ranging from 1 (very slightly or not at all) to 5 (extremely). 10 positive affect items are summed to create a total positive affect score while the 10 negative affect items are summed to create a total negative affect score; higher total scores indicate more positive affect or more negative (i.e., worse) affect. | Prior to drug exposure and for 4 hours post-exposure. |
| Subjective rating of "Drug Effect" as assessed via the Drug Effect Questionnaire | Visual Analog Scale rating of subjective drug effect. Score ranges from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation. | Prior to drug exposure and for 4 hours post-exposure. |