Investigating CBD's effects on opioid use disorder through neuroimaging

Neuroimaging and CBD for Opiod Use Disorder

This study is testing if CBD can help people with opioid use disorder who are on methadone by looking at changes in their brain while they try it for two weeks.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Hurd,Yasmin, Ph.D. (indiv)
• Locations: 1 site (New York, New York)
• Trial ID: NCT04567784 on ClinicalTrials.gov

What this trial studies

This study examines the neurobiological effects of cannabidiol (CBD) in individuals with opioid use disorder who are maintained on methadone. Participants will receive either CBD or a placebo while undergoing multimodal neuroimaging to assess changes in neural circuits and neurotransmitter levels associated with craving and anxiety. The study aims to gather critical data that could support the development of CBD as a non-opioid treatment for opioid use disorder. The research will last for two weeks and includes various imaging techniques and questionnaires to evaluate the impact of CBD on participants' responses to drug cues.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 who are currently maintained on methadone for opioid use disorder.

Not a fit: Patients with severe psychiatric conditions or those not currently on methadone maintenance therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a new non-opioid treatment option for individuals struggling with opioid use disorder.

How similar studies have performed: Previous studies have indicated that CBD may reduce cravings and anxiety in abstinent heroin users, suggesting potential success for this approach.

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.

Where this trial is running

New York, New York

• Icahn School of Medicine at Mount Sinai — New York, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Yasmin Hurd, PhD — Icahn School of Medicine at Mount Sinai
• Study coordinator: Ashanta Carter

Conditions: Heroin Abuse, Opioid Use Disorder, Substance-Related Disorders, Opioid-Related Disorders, Heroin, Opioid, Narcotics, Central Nervous System Depressants