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.
Description
In this Phase 2 study, the research team will conduct a double-blind (placebo-controlled) randomized controlled trial to evaluate whether 200mg and/or 400mg CBD (BSPG Laboratories) given twice daily (morning and evening), as compared to placebo, reduces cue-induced craving and anxiety in individuals with opioid use disorder who are maintained on methadone or buprenorphine. In addition to in-lab physiological and behavioral assessments of cue-induced craving and anxiety, the research team will also employ ecological momentary assessment to obtain real-world measures of symptoms including craving, anxiety, and mood.
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.