Substance-Related Disorders Clinical Trial
Official title:
Neuroimaging and CBD for Opiod Use Disorder
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.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | November 12, 2025 |
Est. primary completion date | November 12, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Icahn School of Medicine at Mount Sinai | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Hurd,Yasmin, Ph.D. | Jazz Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adverse Events as assessed by the SAFTEE | The Systematic Assessment for Treatment of Emergent Events (SAFTEE) is a structured instrument for collecting adverse drug effects. | post-intervention, approximately 1 week | |
Primary | 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) | |
Primary | 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) | |
Primary | 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 | Change in cue-induced drug craving on the VAS | Change in cue-induced drug craving will be measured through the Visual Analogue Scale for craving, 0 (not at all) to 10 (extremely) approximately 10 days after enrollment. | 1 week post-intervention | |
Secondary | Change in cue-induced anxiety on the VAS | Change in cue-induced anxiety will be measured through the Visual Analogue Scale for anxiety, 0 (not at all) to 10 (extremely) approximately 10 days after enrollment. | 1 week post-intervention | |
Secondary | Systolic and diastolic blood pressure (in mmHg) | Change in blood pressure. | 2 hours post-dose | |
Secondary | Heart rate (in beats/min) | Change in heart rate. | 2 hours post-dose |
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