A Phase 2 interventional study of Cannabidiol (CBD) and Placebo in Heroin Abuse, Opioid Use Disorder and Substance-Related Disorders, sponsored by Yasmin Hurd. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-10-27.
Sponsored by Yasmin Hurd · Phase 2, Interventional, and Treatment
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.
This study will first use multimodal imaging in individuals with opiod use disorder who are maintained on methadone to determine the neural circuits associated with the effects of CBD on craving and anxiety. Secondly, the investigators will conduct 1H MRS to characterize in-vivo neurochemical levels associated with CBD administration. Altogether, the data obtained will fill critical gaps of knowledge important in the development of a potential non-opioid medication for treating opioid use disorder.
CBD has been shown to be safe in association with opioid use and not to have severe side effects. The oral CBD solution (Epidiolex) to be used in the current study is approved by the FDA for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients 2 years of age and older. Our study will investigate the neurobiological effects of CBD which is critical for its development as a potential treatment for opioid use disorder in the future. Study participation duration will last 2 weeks and will include multimodal imaging techniques to examine neural connectivity, neural activity and glutamate (and other neurometabolites) levels in relation to the impact on cue-induced responses in OUD subjects. The imagining sessions will include CBD/placebo administration; Magnetic Resonance Imaging (MRI) during task and resting-state functional MRI (rs-fMRI) and Magnetic Resonance spectroscopy (MRS); and questionnaires measuring craving, anxiety, depression, elements of cognitive function, and psychiatric history.
Screening: Study candidates will be recruited through flyers, ads and referrals from AIMS clinics. At the initial phone contact candidates will be screened for exclusion criteria and provided study information and, if they remain interested and no exclusion criteria are encountered, invited for in-person screening. Candidates will then undergo the informed consent procedure, be fully screened for eligibility and complete baseline assessments.
Randomization: Participants will be randomly assigned to either CBD or Placebo condition.
90 studies on the registry are indexed under Heroin Dependence; 1 is open to participants now.
This study's enrollment of 66 is below the median of 87 across 57 interventional studies indexed under Heroin Dependence.
Browse Heroin Dependence studies →Yasmin Hurd is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a harmless, inactive solution to compare and validate the results of the other arms of the study
Drug: Placebo
Participants in Arm CBD 800 mg will receive 800mg of Cannabidiol in each of the three test sessions
Drug: Cannabidiol (CBD)
CBD 800 mg Cannabidiol - oral CBD solution
Also known as: Epidiolex
inactive solution
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.
Time frame: 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.
Time frame: 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.
Time frame: 2 MRI Scans (duration 10 mins)
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.
Time frame: 1 week post-intervention
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.
Time frame: 1 week post-intervention
Systolic and diastolic blood pressure (in mmHg)
Change in blood pressure.
Time frame: 2 hours post-dose
Heart rate (in beats/min)
Change in heart rate.
Time frame: 2 hours post-dose
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.
Time frame: post-intervention, approximately 1 week
Plan to share: No — IPD is not to be shared with other researchers.
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cannabidiol
Yasmin Hurd