Safety and Tolerability of Cannabidiol Among Persons With Opioid Use Disorder Receiving Methadone or Buprenorphine

Inclusion Criteria:

• Men and women aged between 18 and 70 years old.

• Diagnosed with OUD and currently enrolled in methadone or buprenorphine maintenancetreatment.

• Having chronic pain, uniformly operationalized as grade II (high-intensity) non-cancer pain for ≥ 6 months 49.

• Capable of providing informed consent in English.

• Compliant in opioid maintenance treatment and on a stable dose for four weeks orlonger.

• Not meeting DSM-5 criteria for substance use disorders other than OUD or tobacco usedisorder within the last 12 months.

• No current medical problems deemed contraindicated for participation by principalinvestigator.

• For women, not pregnant as determined by pregnancy screening; not breast-feeding;using acceptable birth control methods. Acceptable contraception for women includesoral contraceptives, contraceptive depot injections, contraceptive subdermalimplants, intrauterine devices, or surgical contraception methods. Acceptablecontraception for men includes condoms or surgical contraception methods.

Exclusion Criteria:

• Other current major psychiatric disorders deemed clinically unstable by theprincipal investigator, such as severe depression and/or active suicidal ideation.

• Having experienced major psychosocial stressors recently (≤ 6 weeks beforeenrollment), at the discretion of the principal investigator.

• Methadone dose under 60mg or over 100mg

• Buprenorphine over 24mg.

• Having received inpatient psychiatric treatment recently (≤ 60 days beforeenrollment).

• Candidates receiving products containing either THC or CBD will be excluded.

• Current use regular use other prescription opioids, gabapentinoids (pregabalin,gabapentin), antidepressants (SSRIs, SNRIs, TCAs), benzodiazepines, plateletinhibitors (e.g., clopidogrel, apixaban, ticagrelor), or NSAIDs.

• Current weight of less of 60 kg.

• Allergy to sesame seed oil, which is an ingredient of the CBD formulation used.

• Serious medical or neurological illness or treatment for a medical disorder thatcould interfere with study participation as determined by principal investigator.

• Participants who have elevation of liver enzymes (ALT and/or AST) 2x above thenormal limit or higher.