Overview

The long-term goal of the project is to determine whether cannabidiol (CBD) can reduce craving and relapse in individuals with opioid use disorder (OUD). The first phase of our project was an open cross-over design study in healthy individuals to confirm the safety and pharmacokinetic (PK) effects of CBD. This next phase is to determine whether CBD can serve as a potential adjunct treatment to reduce craving and anxiety in individuals with OUD maintained on opioid agonist therapy.

Eligibility

INCLUSION CRITERIA:

        An individual who meets all of the following criteria will be eligible for study
        participation:
          -  Individuals between 18 and 65 years old
          -  Ability to understand and give informed consent.
          -  Current opioid use disorder (OUD) or OUD in remission while on maintenance therapy
             with OAT, as determined by DSM-5 with the M.I.N.I. interview (Mini-International
             Neuropsychiatric Interview).
          -  Current opioid agonist maintenance treatment in an opioid treatment program with
             methadone or buprenorphine for at least 14 days prior to study participation. With the
             following more specific criteria for each of these two medications:
               -  Current methadone maintenance treatment with a dose of ≥ 40mg/day, (maximum:
                  200mg/day), AND urinary toxicology positive for methadone and EDDP; OR
               -  Current buprenorphine maintenance treatment with a dose of ≥ 8mg/day (maximum:
                  24mg/day), AND urinary toxicology positive for buprenorphine.
        EXCLUSION CRITERIA:
        An individual who meets any of the following criteria will be excluded from participation:
          -  Participants who are non-English speaking.
          -  Psychiatric conditions under DSM-5 (examined with the MINI) that would make study
             participation unsafe or which would prevent adherence to study procedure; examples
             include: suicidal or homicidal ideation requiring immediate attention,
             inadequately-treated mental health disorder (e.g., active psychosis, uncontrolled
             bipolar disorder).
          -  Current diagnosis of a severe substance use disorder (except for opioid and
             nicotine/tobacco) in the past 3 months, based on the MINI interview, that would
             preclude safe participation in the study as determined by the study medical clinician.
          -  Alcohol intoxication when arriving at the study site (i.e., positive alcohol
             breathalyzer / alcohol salivary strips / urine alcohol).
          -  Signs of acute drug intoxication when arriving at the study site as determined by
             clinician assessment.
          -  Medical or psychiatric contraindications for CBD administration (e.g., history of
             hypersensitivity to cannabinoids); or any of the ingredients in the product (gelatin
             or sesame oil).
          -  Showing signs of acute opioid withdrawal symptoms (as determined by the result of the
             Clinical Opiate Withdrawal Scale (COWS). A Score of ≥ 5 or as interpreted by the
             investigator will be considered a positive result for withdrawal symptoms).
          -  Have a medical condition that would make study participation unsafe, which would make
             treatment compliance difficult, or would prevent adherence to study procedure. This
             includes, but is not limited to the following criteria:
               -  History of impaired renal function or elevated liver enzymes at prescreening. The
                  exclusionary lab values are: >4x the upper limit of normal (ULN) per laboratory
                  criteria for AST or ALT, >1.5x ULN for bilirubin or <30mL/min/1.73m2 eGFR
               -  QTc Frederica > 500ms
          -  Participating in another pharmacotherapeutic trial in the past 3 months.
          -  Participants who have used any medication, dietary supplements (and/or grapefruit
             juice), or combination of medications and supplements known to alter the metabolism
             of, or interact with CBD (buproprion, rifampin, barbiturates, phenothiazines,
             cimetidine, etc.) 14 days prior to and during the duration of the study
          -  For women: being pregnant (positive urine test for pregnancy) or breastfeeding.
          -  Not using an appropriate method of contraception such as hormonal contraception (oral
             hormonal contraceptives, Depo-Provera, Nuva-Ring), intrauterine device (IUD),
             sterilization, or double barrier method (combination of any two barrier methods used
             simultaneously, i.e. condom, spermicide, diaphragm).
          -  Participants who have been court mandated to attend treatment centers.