CBD Oil And Methadone

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Natural Medicines, the Authority on Integrative Medicine Safety of Cannabidiol Given to Subject With Methadone or Buprenorphine The overarching goal of this study is to evaluate the potential of Cannabidiol (CBD) as an adjunctive treatment for comorbid

CBD Oil And Methadone

A new report suggests that taking cannabidiol (CBD) might increase methadone levels and increase its side effects. This is especially concerning in chronic pain settings such as cancer.

A 13-year-old patient with chronic cancer pain who was previously stabilized on methadone 7.5 mg twice daily was admitted to the ER with opioid-related side effects. These side effects started 5 days prior to the ER visit, which occurred about 2 weeks after her parents increased her dose of CBD oil 4-fold. After stopping CBD, the side effects resolved. CBD may increase methadone levels by inhibiting the cytochrome P450 3A4 (CYP3A4) and CYP2C19 enzymes, which metabolize methadone. This is the first case report suggesting there is an interaction between CBD and methadone. The interaction appears to be dose-dependent – in this case, it occurred with a very high dose of CBD but not with a much lower dose. More evidence is needed to verify this interaction and to determine the CBD dose threshold at which it might occur.

Many patients and their families don’t disclose the use of natural medicines such as CBD and other cannabis products to their healthcare providers. It’s important to discuss the use of all cannabis-derived products with patients and their families. Healthcare providers should ask directly about CBD use and be aware of its potential drug interactions.

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  • Is CBD Safe During Pregnancy?

The information in this brief report is intended for informational purposes only, and is meant to help users better understand health concerns. This information should not be interpreted as specific medical advice. Users should consult with a qualified healthcare provider for specific questions regarding therapies, diagnosis and/or health conditions, prior to making therapeutic decisions. Copyright © 2022 Natural Medicines Inc. Commercial distribution or reproduction prohibited. Natural Medicines is the leading provider of high-quality, evidence-based, clinically-relevant information on natural medicine, dietary supplements, herbs, vitamins, minerals, functional foods, diets, complementary practices, CAM modalities, exercises and medical conditions. Monograph sections include interactions with herbs, drugs, foods and labs, contraindications, depletions, dosing, toxicology, adverse effects, pregnancy and lactation data, synonyms, safety and effectiveness.

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Safety of Cannabidiol Given to Subject With Methadone or Buprenorphine

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.

Condition or disease Intervention/treatment Phase
Addiction Drug: CBD Day 1 Drug: CBD Day 2 Drug: CBD Day 3 Early Phase 1

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.

Layout table for study information

Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cannabidiol Pharmacotherapy for Comorbid Opioid Addiction and Chronic Pain
Actual Study Start Date : December 8, 2021
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : July 30, 2023
    Pain Threshold [ Time Frame: 4 measurements per test day, 3 total test days ]
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The Cold Pressor (CPT measures Pain threshold (in seconds). For this test, a cooler filled with cold water (32.9-34.7degrees F/0.5-1.5 degrees C) are used. Participants are instructed to immerse their hand into the water and report the first time they experience pain (pain threshold). Lower scores indicate lower pain threshold. Minimum score is 0 seconds, and a maximum cut-off score of 300 seconds is used to prevent tissue damage.

The Cold Pressor Test (CPT) measures pain threshold and pain tolerance (in seconds). For this test, a water cooler is filled with cold water (32.9-34.7ºF/0.5-1.5ºC) are used. To begin the CPT, Participants are then instructed to immerse their hand into the cold water bath and report when the pain becomes unbearable (pain tolerance). Lower scores indicate lower pain tolerance. Minimum score is 0 seconds, and a maximum cut-off score of 300 seconds is used to prevent tissue damage.

The QST is a reliable, dynamic, and computerized method of quantifying distinct mechanisms of the pain experience

The QST is a reliable, dynamic, and computerized method of quantifying distinct mechanisms of the pain experience

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
  • 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.
  • 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.
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05076370

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