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Neuroimaging and CBD for Opioid Use Disorder

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Conditions

Heroin AbuseOpioid Use DisorderSubstance-Related DisordersOpioid-Related DisordersHeroinOpioidNarcoticsCentral Nervous System DepressantsAnalgesicsFunctional neuroimagingMagnetic resonance spectroscopy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The investigators propose an imaging study to investigate the neurobiological effects of CBD (vs placebo) in participants with opioid use disorder who are maintained on methadone. The purpose of the study is to determine the neural circuits and transmitters associated with the effects of CBD on to reduce craving and anxiety. The neuroimaging will be conducted in participants immediately following their first administration of CBD (800mg or placebo) and one week after the last administration (3 daily doses). This CBD administration protocol was shown in previous studies by the investigators to reduce craving and anxiety in abstinent heroin users.

Official Title

Neuroimaging and CBD for Opioid Use Disorder

Quick Facts

Study Start:2020-11-12
Study Completion:2025-06-18
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04567784

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion 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.
  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.

Contacts and Locations

Principal Investigator

Yasmin Hurd, PhD
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Yasmin Hurd

  • Yasmin Hurd, PhD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-11-12
Study Completion Date2025-06-18

Study Record Updates

Study Start Date2020-11-12
Study Completion Date2025-06-18

Terms related to this study

Keywords Provided by Researchers

  • Heroin
  • Opioid
  • Narcotics
  • Central Nervous System Depressants
  • Analgesics
  • Functional neuroimaging
  • Magnetic resonance spectroscopy

Additional Relevant MeSH Terms

  • Heroin Abuse
  • Opioid Use Disorder
  • Substance-Related Disorders
  • Opioid-Related Disorders