Heroin AbusePhase 2NCT04567784
Neuroimaging and CBD for Opioid Use Disorder
A Phase 2 study testing Cannabidiol (CBD) in people with Heroin Abuse and Opioid Use Disorder, run by Yasmin Hurd at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Heroin Abuse, Opioid Use Disorder, Substance-Related Disorders
- What is being tested?
- Cannabidiol (CBD)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2020to 18 Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
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.
Read the detailed description
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.
- Being tested
- Cannabidiol (CBD), Placebo
- Keywords
- Heroin, Opioid, Narcotics, Central Nervous System Depressants, Analgesics, Functional neuroimaging, Magnetic resonance spectroscopy
- Medical subject headings
- Heroin Dependence, Opioid-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol (CBD)Drug
Also called Epidiolex
CBD 800 mg Cannabidiol - oral CBD solution
PlaceboDrug
inactive solution
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Participants will receive a harmless, inactive solution to compare and validate the results of the other arms of the study Receives: Drug: Placebo |
| CBD 800mg | Experimental | Participants in Arm CBD 800 mg will receive 800mg of Cannabidiol in each of the three test sessions Receives: Drug: Cannabidiol (CBD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 2 MRI Scans (duration 10 mins)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 1 week post-intervention
Systolic and diastolic blood pressure (in mmHg)
Change in blood pressure.
Measured: 2 hours post-dose
Heart rate (in beats/min)
Change in heart rate.
Measured: 2 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start12 Nov 2020
- Primary completion18 Jun 2025
- Study completion18 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heroin AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a randomized clinical trial in which subjects will receive either placebo or 800mg cannabidiol (CBD).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yasmin Hurd
- Sponsor type
- University, hospital or other
- Collaborators
- GW Research Ltd
- Responsible party
- Sponsor-investigator, Yasmin Hurd, Icahn School of Medicine at Mount Sinai
- Investigators
- Yasmin Hurd, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567784
- Sponsor's protocol ID
- HS#: 19-00293
- Status last verified
- Oct 2025
- First submitted
- 30 Jul 2020
- Last updated
- 27 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD is not to be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging and CBD for Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT04567784
- Acronym / sponsor ID
- HS#: 19-00293
- Keywords
- Heroin, Opioid, Narcotics, Central Nervous System Depressants, Analgesics, Functional neuroimaging, Magnetic resonance spectroscopy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Yasmin HurdUniversity, hospital or other
- Collaborators
- GW Research Ltd
- Study start
- 12 Nov 2020 (actual)
- Primary completion
- 18 Jun 2025 (actual)
- Study completion
- 18 Jun 2025 (actual)
- First posted
- 29 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a randomized clinical trial in which subjects will receive either placebo or 800mg cannabidiol (CBD).
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: PlaceboParticipants will receive a harmless, inactive solution to compare and validate the results of the other arms of the study |
| CBD 800mg | Experimental | Drug: Cannabidiol (CBD)Participants in Arm CBD 800 mg will receive 800mg of Cannabidiol in each of the three test sessions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabidiol (CBD)Also: EpidiolexCBD 800 mg Cannabidiol - oral CBD solution | Drug | CBD 800mg |
| Placeboinactive solution | Drug | Control |
Primary outcome
CBD effects on in vivo glutamatergic levels within mesocorticolimbic brain regions
Time frame: 2 MRI Scans (duration 30 mins)
Effects of CBD on in-vivo glutamatergic levels within mesocorticolimbic brain regions using Proton-Magnetic resonance spectroscopy.
Change in fMRI BOLD signal during cue reactivity
Time frame: 2 MRI Scans (duration 15 mins)
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.
Change in fMRI BOLD signal acquired during resting-state functional connectivity
Time frame: 2 MRI Scans (duration 10 mins)
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.
4 secondary outcomes
Change in cue-induced drug craving on the VAS
Time frame: 1 week post-intervention
Change in cue-induced anxiety on the VAS
Time frame: 1 week post-intervention
Systolic and diastolic blood pressure (in mmHg)
Time frame: 2 hours post-dose
Heart rate (in beats/min)
Time frame: 2 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
- Individual participant dataSharing planned: No. IPD is not to be shared with other researchers.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasmin Hurd, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cannabidiol (CBD) in people with Heroin Abuse and Opioid Use Disorder, run by Yasmin Hurd at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CBD effects on in vivo glutamatergic levels within mesocorticolimbic brain regions (time frame: 2 MRI Scans (duration 30 mins)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2025; AzTrials last refreshed its copy on 31 Oct 2026.