Clinical trial NCT06206291: Cannabidiol in the Treatment of Opioid Use Disorder
Official title: Cannabidiol in the Treatment of Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid Use Disorder
Keywords: CBD
Cannabidiol
Methadone
Buprenorphine
Opioid Use Disorder
OUD
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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 criteria: 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.

Primary outcomes:
measure: Change in Visual Analog Scale for Craving (VASC)
timeFrame: Baseline and 4 weeks
measure: Change in Visual Analog Scale Anxiety (VASA)
timeFrame: Baseline and 4-weeks
measure: Proportion of participants with positive urine toxicology
timeFrame: 4-weeks
measure: Systematic Assessment for Treatment Emergent Events (SAFTEE)
timeFrame: weekly for 8 weeks
Secondary outcomes:
measure: Change in Visual Analog Scale for craving (VASC)
timeFrame: baseline and 4-weeks
measure: Change in Visual Analog Scale for craving (VASC)
timeFrame: 4-weeks and 8-weeks
measure: Change in Visual Analog Scale Anxiety (VASA)
timeFrame: baseline and 4-weeks
measure: Change in Visual Analog Scale Anxiety (VASA)
timeFrame: 4-weeks and 8-weeks
measure: Change in proportion of participants with positive urine toxicology
timeFrame: 4 weeks and 8 weeks
measure: Change in Heroin Craving Questionnaire Short Form (HCQ-SF-14)
timeFrame: baseline and 4-weeks
measure: Change in Heroin Craving Questionnaire Short Form (HCQ-SF-14)
timeFrame: 4-weeks and 8-weeks
measure: Change in Generalized Anxiety Disorder Scale (GAD-7)
timeFrame: baseline and 4-weeks
measure: Change in Generalized Anxiety Disorder Scale (GAD-7)
timeFrame: 4-weeks and 8-weeks
measure: Duration of participant first illicit opioid abstinence
timeFrame: any time during study, 8 weeks
measure: Change in Patient Health Questionnaire (PHQ-9)
timeFrame: baseline and 4-weeks
measure: Change in Patient Health Questionnaire (PHQ-9)
timeFrame: 4-weeks and 8-weeks
measure: Positive and Negative Affect Schedule (PANAS-SF)
timeFrame: baseline and 4-weeks
measure: Positive and Negative Affect Schedule (PANAS-SF)
timeFrame: 4-weeks and 8-weeks
measure: Change in Heart rate
timeFrame: baseline and 8-weeks
measure: Change in Blood pressure
timeFrame: baseline and 8-weeks
measure: Change in Body Temperature
timeFrame: baseline and 8-weeks
measure: Change in Oxygen level
timeFrame: baseline and 8-weeks
measure: Change in Cue-induced salivary cortisol levels
timeFrame: baseline and 4-weeks
measure: Change in Cue-induced salivary cortisol levels
timeFrame: 4-weeks and 8-weeks
measure: Sleep duration
timeFrame: up to 8-weeks
measure: Change in Insomnia Severity Index (ISI)
timeFrame: baseline and 8-weeks
measure: Change in The Digit Span Test subtest of the Wechsler Adult Intelligence Scale 4th edition
timeFrame: baseline and 8-weeks
measure: Change in The Symptom Check List 90 (SCL-90)
timeFrame: baseline and 8-weeks
measure: Change in Substance use other than opioids in urine
timeFrame: baseline and 4-weeks
measure: Change in Substance use other than opioids in urine
timeFrame: 4-weeks and 8 weeks
measure: Change in Substance use other than opioids in blood
timeFrame: baseline and 4-weeks
measure: Change in Substance use other than opioids in blood
timeFrame: 4-weeks and 8 weeks
measure: Change in Concentration of methadone or buprenorphine metabolites in urine
timeFrame: baseline and 4-weeks
measure: Change in Concentration of methadone or buprenorphine metabolites in urine
timeFrame: 4-weeks and 8-weeks
measure: Change in Concentration of methadone or buprenorphine metabolites in blood
timeFrame: baseline and 4-weeks
measure: Change in Concentration of methadone or buprenorphine metabolites in blood
timeFrame: 4-weeks and 8-weeks
measure: Number of participants remaining in treatment
timeFrame: up to 8 weeks
measure: Change in Change in dosage of opioid agonist treatment
timeFrame: baseline and 8 weeks
measure: Number of positive urine toxicology
timeFrame: 4 weeks
measure: Number of positive blood toxicology
timeFrame: 4 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Yasmin Hurd, PhD
role: PRINCIPAL_INVESTIGATOR
References: