Neuroimaging and CBD for Opioid Use Disorder

NCT04567784 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: HS#: 19-00293
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• CBD effects on in vivo glutamatergic levels within mesocorticolimbic brain regions

  Effects of CBD on in-vivo glutamatergic levels within mesocorticolimbic brain regions using Proton-Magnetic resonance spectroscopy.

  2 MRI Scans (duration 30 mins)

• Change in fMRI BOLD signal during cue reactivity

  Change in fMRI blood-oxygen-level dependent (BOLD) signal acquired during the cue reactivity task at the 2nd MRI conducted 1 week after intervention as compared to the 1st MRI.

  2 MRI Scans (duration 15 mins)

• Change in fMRI BOLD signal acquired during resting-state functional connectivity

  Change in fMRI blood-oxygen-level dependent (BOLD) signal acquired during resting-state at the 2nd MRI conducted 1 week after intervention as compared to the 1st MRI.

  2 MRI Scans (duration 10 mins)

Secondary Outcomes (4)

• Change in cue-induced drug craving on the VAS

  1 week post-intervention

• Change in cue-induced anxiety on the VAS

  1 week post-intervention

• Systolic and diastolic blood pressure (in mmHg)

  2 hours post-dose

• Heart rate (in beats/min)

  2 hours post-dose

Other Outcomes (1)

• Adverse Events as assessed by the SAFTEE

  post-intervention, approximately 1 week

Study Arms (2)

Control

PLACEBO COMPARATOR

Participants will receive a harmless, inactive solution to compare and validate the results of the other arms of the study

Drug: Placebo

CBD 800mg

EXPERIMENTAL

Participants in Arm CBD 800 mg will receive 800mg of Cannabidiol in each of the three test sessions

Drug: Cannabidiol (CBD)

Interventions

Cannabidiol (CBD) DRUG

CBD 800 mg Cannabidiol - oral CBD solution

Also known as: Epidiolex

CBD 800mg

Placebo DRUG

inactive solution

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals between 18 and 65 years old.
• 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.
• 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).
• Urinary toxicology positive for methadone.

You may not qualify if:

• Non-English speaking.
• Court mandate to treatment.
• Participation in another pharmacotherapeutic trial in the past 3 months.
• 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.
• 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).
• History of impaired renal function or elevated liver enzymes \>2x the normal at prescreening.
• QTc Frederica \>500ms.
• Current pregnancy \[determined by positive urine test\] 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).
• Medical or psychiatric contraindications for MRI (metal implants, stents, etc).
• Medical or psychiatric contraindications for CBD administration (e.g., history of hypersensitivity to cannabinoids).
• Current diagnosis of a moderate or severe substance use disorder (except for opioids and nicotine) in the past 3 months, based on DSM-5.
• Acute drug intoxication as determined by clinician assessment.
• 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.
• Breathalyzer/Alcohol salivary/urine strips positive for alcohol.

Sponsors & Collaborators

• Yasmin Hurd: lead
• GW Research Ltd: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Heroin Dependence; Opioid-Related Disorders; Substance-Related Disorders

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Yasmin Hurd, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: This study is a randomized clinical trial in which subjects will receive either placebo or 800mg cannabidiol (CBD).

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: September 29, 2020
• Study Start: November 12, 2020
• Primary Completion: June 18, 2025
• Study Completion: June 18, 2025
• Last Updated: October 27, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)