Cannabidiol in the Treatment of Opioid Use Disorder
Condition: Opioid Use Disorder
MeSH terms: Opioid-Related Disorders; Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of the current study is to evaluate the bioavailability of CBD in normal healthy
      Individuals. This is an open cross-overdesign study in healthy individuals to assess the
      safety and pharmacokinetic (PK) effects of cannabidiol.
    

Detailed description: 
      The goal of this study is to determine the pharmacokinetics and pharmacodynamic profile of
      CBD in normal healthy individuals under standard and high fat fed conditions.

      CBD has recently gained significant attention as a potential treatment for various disorders.
      One aspect for consideration in the development of CBD medication in capsule form is the poor
      bioavailability of cannabinoids such as CBD to obtain clinically effective doses since only
      ~4-6% of CBD is absorbed orally. This study will investigate the potential of CBD in a
      formulation in a capsule to enhance bioavailability, reduce the incidence of gastrointestinal
      side effects, reduce first pass metabolism and enhance onset time. This PK study will be
      conducted with standard meal and high fat conditions in normal healthy volunteers in a
      cross-over design, separated by a washout period of 1 week. Healthy volunteers are defined as
      having no significant health-related issues (i.e., the absence of significant medical,
      psychosocial, or emotional conditions) that are verified by clinical and psychiatric
      assessments.

      The study will first evaluate in healthy volunteers the PK, tolerability and safety profiles
      of a new CBD formulation designed to improve bioavailability.

      Test conditions and order:

        1. 200 mg CBD (standard meal)

        2. 400 mg CBD (standard meal)

        3. 400 mg Epidiolex (standard meal)

        4. 400 mg CBD (high fat meal)

      Blood samples will be taken at -60,15, 30, 45 and 60 min and1.5, 2, 3, 4, 6, 8, 10, 12 and 24
      hours associated with administration of the CBD capsules.

      Monitoring period for PK: 24 hours (plasma and urine PK). Participation in 4 test conditions
      for a duration of approximately 4 weeks and a 1-week follow-up assessment.

      Total length of in-house stay is 12 hours, with participants returning the following day for
      24-hour time point procedures.
    

Intervention name(s): Cannabidiol 200mg; Epidiolex; Cannabidiol 400mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Cannabidiol 200mg (twice daily); Epidiolex 400mg (twice daily); Cannabidiol 400mg (twice daily); Matching Placebo (Twice Daily)
Other intervention name(s): BSPG CBD; BSPG CBD
Intervention MeSH terms: Cannabidiol
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Study will be conducted using a cross-over design, separated by a 1-week washout period.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: Methadone; Buprenorphine; Opioid Use Disorder