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About
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.
Full 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.
Enrollment
Sex
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Volunteers
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:
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:
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.
Primary purpose
Allocation
Interventional model
Masking
141 participants in 4 patient groups, including a placebo group
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Central trial contact
Ruthie Perez
Data sourced from clinicaltrials.gov
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