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Search / Trial NCT04567784

Neuroimaging and CBD for Opiod Use Disorder

Launched by HURD,YASMIN, PH.D. · Sep 22, 2020

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Heroin Opioid Narcotics Central Nervous System Depressants Analgesics Functional Neuroimaging Magnetic Resonance Spectroscopy

ClinConnect Summary

This clinical trial, called "Neuroimaging and CBD for Opioid Use Disorder," is investigating how CBD (a compound found in cannabis) affects the brain and may help reduce cravings and anxiety in people dealing with opioid use disorder, like heroin addiction. Participants in this study will be individuals aged 18 to 65 who are currently receiving methadone treatment for their opioid addiction. They will take either CBD or a placebo (a non-active substance) and undergo brain imaging to see how their brain reacts immediately after taking CBD and a week after their last dose.

To be eligible, participants must have been on a stable dose of methadone for at least 14 days and must still be experiencing opioid use disorder or be in remission while on treatment. They cannot have certain medical or mental health conditions that could make participation unsafe. Throughout the study, participants will receive three daily doses of CBD or placebo, and their experiences with cravings and anxiety will be monitored. This trial is currently recruiting, and it aims to provide valuable insights into how CBD might help those struggling with opioid addiction.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Individuals between 18 and 65 years old.
  • 2. Current methadone maintenance in an opioid treatment program with a dose of =/\>40mg for at least 14 days prior to participation and prescribed take-home methadone medication.
  • 3. Current opioid use disorder (OUD) or OUD in remission while on maintenance therapy with opioid agonist therapy (OAT), as determined by DSM-5 with the M.I.N.I. interview (Mini-International Neuropsychiatric Interview).
  • 4. Urinary toxicology positive for methadone.
  • Exclusion Criteria:
  • 1. Non-English speaking.
  • 2. Court mandate to treatment.
  • 3. Participation in another pharmacotherapeutic trial in the past 3 months.
  • 4. Poor physical health (as determined by medical screen) that would make study participation unsafe, or would prevent adherence to study procedures, including a history of cardiac disease, arrhythmias, head trauma, and seizures.
  • 5. 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, or inadequately-treated mental health disorder (e.g. active psychosis or uncontrolled bipolar disorder).
  • 6. History of impaired renal function or elevated liver enzymes \>2x the normal at prescreening.
  • 7. QTc Frederica \>500ms.
  • 8. Current pregnancy \[determined by positive urine test\] or breastfeeding.
  • 9. 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).
  • 10. Medical or psychiatric contraindications for MRI (metal implants, stents, etc).
  • 11. Medical or psychiatric contraindications for CBD administration (e.g., history of hypersensitivity to cannabinoids).
  • 12. Current diagnosis of a moderate or severe substance use disorder (except for opioids and nicotine) in the past 3 months, based on DSM-5.
  • 13. Acute drug intoxication as determined by clinician assessment.
  • 14. Acute opioids withdrawal symptoms (observational and determined by the Clinical Opiate Withdrawal Scale (COWS). A Score of ≥#5 will be considered a positive result for withdrawal symptoms and/or by clinical judgment.
  • 15. Breathalyzer/Alcohol salivary/urine strips positive for alcohol.

About Hurd,Yasmin, Ph.D.

Dr. Yasmin Hurd, Ph.D., is a prominent clinical trial sponsor renowned for her pioneering research in the fields of neuroscience and addiction. With extensive expertise in neuropharmacology, Dr. Hurd leads innovative studies aimed at understanding the underlying mechanisms of substance use disorders and developing effective therapeutic strategies. Her commitment to advancing clinical research is reflected in her collaborative approach, engaging multidisciplinary teams to drive impactful findings that can enhance patient outcomes. Through her leadership, Dr. Hurd is dedicated to fostering scientific excellence and translating research discoveries into real-world applications.

Locations

New York, New York, United States

Patients applied

0 patients applied

Trial Officials

Yasmin Hurd, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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