Clinical trial NCT05076370: Safety and Tolerability of Cannabidiol Among Persons With Opioid Use Disorder Receiving Methadone or Buprenorphine
Official title: Cannabidiol Pharmacotherapy for Comorbid Opioid Addiction and Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Addiction
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-10-13
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Initial safety pilot phase of 6 participants,(3 methadone and 3 on Buprenorphine) The general study is a randomized, placebo-controlled, crossover human laboratory study investigating the dose-dependent safety and acute effects of CBD on measures of pain and opioid craving in outpatients with OUD receiving medication-assisted treatment (MAT) with methadone or buprenorphine.
Primary purpose: TREATMENT

Brief summary: The overarching goal of this study is to evaluate the potential of Cannabidiol (CBD) as an adjunctive treatment for comorbid opioid use disorder (OUD) and chronic pain. This is a randomized, placebo-controlled, crossover human laboratory study investigating the dose-dependent safety and acute effects of CBD on measures of pain and opioid craving in outpatients with OUD receiving medication-assisted treatment (MAT) with methadone or buprenorphine.

Detailed description: An initial safety pilot phase will recruit six participants: three receiving treatment with methadone and three receiving treatment with buprenorphine. If the results of the pilot study support the safety of CBD administration in this clinical sample, the general study will recruit 48 participants with comorbid OUD and chronic pain, for a total of 24 completers - 12 subjects (6 men and 6 women) receiving methadone and 12 subjects (6 men and 6 women) receiving buprenorphine. Both sub-studies will enroll participants who do not currently require an inpatient hospitalization.

Eligibility criteria: Inclusion Criteria:

* Males and females, Veterans and non-Veterans, aged between 18 and 70 years old.
* Diagnosed with OUD and currently enrolled in methadone or buprenorphine maintenance treatment.
* 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 or longer.
* Not meeting DSM-5 criteria for substance use disorders other than OUD or tobacco use disorder within the last 12 months.
* No current medical problems deemed contraindicated for participation by principal investigator.
* For women, not pregnant as determined by pregnancy screening; not breast-feeding; using acceptable birth control methods. Acceptable contraception for females includes oral contraceptives, contraceptive depot injections, contraceptive subdermal implants, intrauterine devices, or surgical contraception methods. Acceptable contraception for males includes condoms or surgical contraception methods.

Exclusion Criteria:

* Other current major psychiatric disorders deemed clinically unstable by the principal investigator, such as severe depression and/or active suicidal ideation.
* Having experienced major psychosocial stressors recently (≤ 6 weeks before enrollment), 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 before enrollment).
* 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, platelet inhibitors (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 that could interfere with study participation as determined by principal investigator.
* Participants who have elevation of liver enzymes (ALT and/or AST) 2x above the normal limit or higher.

Primary outcomes:
measure: Agitation Calmness Evaluation Scale (ACES)
timeFrame: 8 hours
measure: Mini Mental Status Examination (MMSE)
timeFrame: 8 hours
measure: Systematic Assessment of Side Effects (SAFTEE)
timeFrame: 8 hours
Secondary outcomes:
measure: Quantitative Sensory Testing (QST)
timeFrame: 8 hours
Other outcomes:
measure: The Heroin Craving Questionnaire - Short Form 14 (HCQ-SF-14)
timeFrame: 8 hours
Locations:
city: West Haven
country: United States
facility: Veteran Affairs Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Joao De Aquino, M.D.
role: PRINCIPAL_INVESTIGATOR
References: