A Phase 1 interventional study of Placebo and Vaporized THC alone in Healthy Volunteers, sponsored by Johns Hopkins University. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-05.
Sponsored by Johns Hopkins University · Phase 1, Interventional, and Basic science
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.
Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
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Exclusion Criteria:
Distilled Water
Drug: Placebo
5mg pure THC
Drug: Vaporized THC alone
50mg pure CBD
Drug: Vaporized CBD alone
100mg pure CBD
Drug: Vaporized CBD alone
200mg pure CBD
Drug: Vaporized CBD alone
50mg pure CBD paired with 5mg THC
Drug: Vaporized CBD with THC
100mg pure CBD paired with 5mg THC
Drug: Vaporized CBD with THC
200mg pure CBD paired with 5mg THC
Drug: Vaporized CBD with THC
Placebo vapor (distilled water)
Also known as: distilled water
Acute exposure to vaporized THC
Acute exposure to vaporized CBD
Acute exposure to vaporized CBD with THC
Change in blood cortisol levels
Peak change in blood cortisol levels in micrograms per deciliter (ug/dl) will be measured
Time frame: 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
Time frame: Prior to drug exposure and for 4 hours post-exposure.
Change in heart rate
Peak change in rate (in beats per minute)
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Prior to drug exposure and for 4 hours post-exposure.
This study is withdrawn, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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