CBD shows promise in easing opioid cravings and anxiety
NCT ID NCT04567784
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how cannabidiol (CBD) affects the brain in people with opioid use disorder who are also taking methadone. Researchers used brain scans to see if CBD could reduce cravings and anxiety. The study involved 66 adults and tested a single dose of CBD or a placebo, with follow-up scans one week later.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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66 people
The number who actually took part.
- Started
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Nov 2020
- Finished
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Jun 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
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Other studies related to the condition(s) this trial covers.
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