The Pharmacokinetics and Pharmacodynamics of Oral and Vaporized Cannabidiol
Condition: Cannabidiol Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the pharmacokinetics and pharmacodynamics of cannabidiol
      administered via inhalation and oral ingestion.
    

Detailed description: 
      The proposed study will be conducted at the Johns Hopkins Behavioral Pharmacology Research
      Unit (BPRU) and the Johns Hopkins Bayview Clinical Research Unit (CRU). Participants will
      complete 4 acute drug administration periods, each consisting of a single drug exposure
      followed by a 5-day observation period (3-days (58-hours) inpatient and 2-days outpatient).
      Biological specimens will be obtained to characterize the pharmacokinetics of THC, CBD, and
      their metabolites in whole blood, oral fluid, urine, and hair during this period. Each
      participant will receive all 4 dose conditions in a counterbalanced order using a placebo
      controlled within-subject crossover design. The 4 drug conditions are as follows:

        -  Condition 1: Inhalation of cannabis vapor containing approximately a 20:1 ratio of
           CBD:THC and will be measured to deliver a target dose of 100mg CBD and 5mg THC.

        -  Condition 2: Inhalation of 100mg CBD vapor.

        -  Condition 3: Ingestion of 100mg CBD.

        -  Condition 4: Placebo

      Drug administration will be double blind and double dummy; both inhalation and oral ingestion
      of study drugs will occur during all 4 sessions. The order of drug administration will be
      counterbalanced across participants.

      Research volunteers will be recruited until up to 18 participants have completed each of the
      four study sessions (received Conditions 1-4). Immediately before (baseline) and following
      each exposure, a battery of assessments including biological fluid collection and testing,
      subjective questionnaire administration, and performance testing will be conducted for all
      study participants. Post-exposure testing will be conducted in two phases: a 3-day (58 hour)
      residential stay, and a 2-day outpatient period, for a total of 5 days. Participants who drop
      out of the study prior to completion of all 4 drug conditions will be considered "incomplete"
      and replaced. Approximately one week (minimum of 6 days) will separate the administration of
      each dose.

      The target demographic for study participation are healthy adults who: 1) have a history of
      intentionally inhaling cannabis/CBD, 2) have not used cannabis in the past month (desire is
      to have participants free of cannabinoids in biological matrices at the time of initial drug
      administration), and 3) who are not currently dependent on or seeking treatment for use of
      cannabis or other psychoactive drugs.

      Study outcome variables include quantitative levels of CBD and its primary metabolites, THC
      and its primary metabolites, results of drug testing procedures conducted in accordance with
      current federal Mandatory Guidelines for workplace drug testing, subjective drug effect
      ratings, and performance on behavioral assessments. Biological specimens will be analyzed by
      an independent laboratory with validated analytical procedures that are specific and accurate
      for measurement of marijuana constituents and related metabolites. Subjective, cardiovascular
      and behavioral outcomes will be assessed using multiple regression analyses appropriate for
      repeated measures testing based on the final characteristics of the data set (e.g. normal
      distribution, skewness, kurtosis), and correlated with biomarker results of interest.
    

Intervention name(s): Oral or vaporized cannabidiol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Acute drug exposure; Placebo capsule/vapor
Intervention MeSH terms: Cannabidiol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science