Opioid-use DisorderPhase 2CURBNCT04192370
Cannabidiol Use to Reduce Cravings in Individuals With Opioid Use Disorder on Buprenorphine
A Phase 2 study testing Cannabidiol 600mg in people with Opioid-use Disorder, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The purpose of this week-long study is to determine the impact of cannabidiol on cue-induced cravings among individuals with opioid use disorder who are stable on sublingual buprenorphine treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- Cannabidiol 600mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2020to 30 Dec 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) opioid use disorder, severe
- Currently in treatment with methadone or buprenorphine
Who cannot join
- Requiring level of care higher than outpatient treatment for alcohol, sedative/hypnotics, or stimulants
- Any current mood episode requiring level of care higher than outpatient treatment
- History of psychotic disorder or bipolar disorder
- Currently pregnant
- Hepatic liver enzymes greater than 3x upper normal limit
- Hypersensitivity to cannabinoids or sesame oil (cannabidiol solution comes in sesame oil emulsion)
- Currently taking any medications with known significant pharmacokinetic interactions with CBD
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: A Single-arm, Open-label Feasibility Pilot of Cannabidiol as an Adjunct to Sublingual Buprenorphine on Cue-induced Cravings Among Individuals With Opioid Use Disorder
The purpose of this week-long study is to determine the impact of cannabidiol on cue-induced cravings among individuals with opioid use disorder who are stable on sublingual buprenorphine treatment.
Read the detailed description
Studies have indicated that medication treatment for opioid use disorder (OUD) with buprenorphine, methadone, or extended-release naltrexone reduces the risk for overdose by 70%. However, treatment dropout rates remain unacceptably high, with approximately 50% of patients discontinuing treatment 6 months after initiation. There is a substantial body of research indicating that high rates of treatment discontinuation are due to the emergence of intense cravings to use illicit opioids in response to cues - which are reminders of the drug such as drug paraphernalia. Much of the research so far in improving treatment retention on medications for OUD have focused on helping patients learn how to avoid triggers and to manage their cravings if they do emerge, and psychosocial treatments as adjuncts to medications has similarly not been as helpful as hoped. As such, there is a critical need to identify novel strategies that will improve retention in medical treatment for OUD, and cannabidiol (CBD) has emerged as a possible adjunct to OUD treatment, as it appears to target brain regions that mediate cue-induced cravings. Two studies so far have shown that CBD reduces cue-induced cravings for abstinent individuals with OUD not taking any medications, but the impact of CBD on cue-induced cravings among individuals stabilized on buprenorphine is not known.
Given that long-term medication treatment remains the gold-standard approach, a critical question that remains unanswered is whether CBD can be used as an adjunct to buprenorphine treatment to reduce cue-induced cravings. As such, the purpose of this week-long open-label feasibility pilot is to determine the impact of cannabidiol on cue-induced cravings among individuals with opioid use disorder who are stable on sublingual buprenorphine treatment. Patients with OUD currently receiving treatment with sublingual buprenorphine will be eligible to enroll. The cue-induced cravings assessment will be conducted before and after the CBD administration.
- Conditions
- Opioid-use Disorder
- Being tested
- Cannabidiol 600mg
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol 600mgDrug
Also called CBD, Epidiolex
All subjects will receive 600mg of oral cannabidiol for 3 days in an open-label fashion. Cannabidiol will be provided using Epidiolex™ oral solution 100mg/mL, and the drug will be procured by the Brigham and Women's Hospital (BWH) Investigational Drug Services (IDS) pharmacy. The first dose will be administered at the BWH Center for Clinical Investigation, while doses 2 and 3 will be self-administrated at home. The CBD will be repacked in pre-drawn syringes for the subjects to self-administer at home.
| Study group | Role | What they receive |
|---|---|---|
| Cannabidiol | Experimental | As this is a single-arm, open-label study, all subjects will receive the interventional arm, specifically 600mg of oral cannabidiol once daily for 3 consecutive days. Receives: Drug: Cannabidiol 600mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cue-induced Cravings and Anxiety After 3 Days of Cannabidiol Administration
Change in cue-induced cravings and anxiety measured before and after 3 days of cannabidiol administration. Subjects will use the Cue-Induced Opioid Craving and Anxiety Scales to note their responses using a visual analog scale of 0 to 10, 0 being "not at all" and 10 being "extremely." Higher scores thus mean a "worse" outcome (i.e. more intense cravings/anxiety).
Measured: pre-exposure (Visit 2, which is day 2 of the 5-day study) and post-exposure (Visit 3, which is day 5 of the 5-day study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start3 Aug 2020
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joji Suzuki, MD, Brigham and Women's Hospital
- Investigators
- Joji Suzuki, M.D., Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192370
- Sponsor's protocol ID
- 2019P003384
- Acronym
- CURB
- Status last verified
- Apr 2023
- First submitted
- 4 Dec 2019
- Last updated
- 18 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Suzuki J, Martin B, Prostko S, Chai PR, Weiss RD. Cannabidiol Effect on Cue-Induced Craving for Individuals with Opioid Use Disorder Treated with Buprenorphine: A Small Proof-of-Concept Open-Label Study. Integr Med Rep. 2022 Aug 1;1(1):157-163. doi: 10.1089/imr.2022.0070. Epub 2022 Aug 26.
PubMed 36105269
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label Feasibility Pilot of Cannabidiol as an Adjunct to Sublingual Buprenorphine on Cue-induced Cravings Among Individuals With Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT04192370
- Acronym / sponsor ID
- CURB / 2019P003384
- Conditions
- Opioid-use Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 10 Dec 2019 (actual)
- Results
- Posted 18 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this week-long study is to determine the impact of cannabidiol on cue-induced cravings among individuals with opioid use disorder who are stable on sublingual buprenorphine treatment.
Detailed description
Studies have indicated that medication treatment for opioid use disorder (OUD) with buprenorphine, methadone, or extended-release naltrexone reduces the risk for overdose by 70%. However, treatment dropout rates remain unacceptably high, with approximately 50% of patients discontinuing treatment 6 months after initiation. There is a substantial body of research indicating that high rates of treatment discontinuation are due to the emergence of intense cravings to use illicit opioids in response to cues - which are reminders of the drug such as drug paraphernalia. Much of the research so far in improving treatment retention on medications for OUD have focused on helping patients learn how to avoid triggers and to manage their cravings if they do emerge, and psychosocial treatments as adjuncts to medications has similarly not been as helpful as hoped. As such, there is a critical need to identify novel strategies that will improve retention in medical treatment for OUD, and cannabidiol (CBD) has emerged as a possible adjunct to OUD treatment, as it appears to target brain regions that mediate cue-induced cravings. Two studies so far have shown that CBD reduces cue-induced cravings for abstinent individuals with OUD not taking any medications, but the impact of CBD on cue-induced cravings among individuals stabilized on buprenorphine is not known.
Given that long-term medication treatment remains the gold-standard approach, a critical question that remains unanswered is whether CBD can be used as an adjunct to buprenorphine treatment to reduce cue-induced cravings. As such, the purpose of this week-long open-label feasibility pilot is to determine the impact of cannabidiol on cue-induced cravings among individuals with opioid use disorder who are stable on sublingual buprenorphine treatment. Patients with OUD currently receiving treatment with sublingual buprenorphine will be eligible to enroll. The cue-induced cravings assessment will be conducted before and after the CBD administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cannabidiol | Experimental | Drug: Cannabidiol 600mgAs this is a single-arm, open-label study, all subjects will receive the interventional arm, specifically 600mg of oral cannabidiol once daily for 3 consecutive days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) opioid use disorder, severe
- Currently in treatment with methadone or buprenorphine
Key exclusion criteria (7 listed)
- Requiring level of care higher than outpatient treatment for alcohol, sedative/hypnotics, or stimulants
- Any current mood episode requiring level of care higher than outpatient treatment
- History of psychotic disorder or bipolar disorder
- Currently pregnant
- Hepatic liver enzymes greater than 3x upper normal limit
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 600mgAlso: CBD, EpidiolexAll subjects will receive 600mg of oral cannabidiol for 3 days in an open-label fashion. Cannabidiol will be provided using Epidiolex™ oral solution 100mg/mL, and the drug will be procured by the Brigham and Women's Hospital (BWH) Investigational Drug Services (IDS) pharmacy. The first dose will be administered at the BWH Center for Clinical Investigation, while doses 2 and 3 will be self-administrated at home. The CBD will be repacked in pre-drawn syringes for the subjects to self-administer at home. | Drug | Cannabidiol |
Primary outcome
Change in Cue-induced Cravings and Anxiety After 3 Days of Cannabidiol Administration
Time frame: pre-exposure (Visit 2, which is day 2 of the 5-day study) and post-exposure (Visit 3, which is day 5 of the 5-day study)
Change in cue-induced cravings and anxiety measured before and after 3 days of cannabidiol administration. Subjects will use the Cue-Induced Opioid Craving and Anxiety Scales to note their responses using a visual analog scale of 0 to 10, 0 being "not at all" and 10 being "extremely." Higher scores thus mean a "worse" outcome (i.e. more intense cravings/anxiety).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36105269Suzuki J, Martin B, Prostko S, Chai PR, Weiss RD. Cannabidiol Effect on Cue-Induced Craving for Individuals with Opioid Use Disorder Treated with Buprenorphine: A Small Proof-of-Concept Open-Label Study. Integr Med Rep. 2022 Aug 1;1(1):157-163. doi: 10.1089/imr.2022.0070. Epub 2022 Aug 26.
- Individual participant dataSharing planned: No
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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.
Joji Suzuki, M.D. principal investigator
Brigham and Women's Hospital
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 600mg in people with Opioid-use Disorder, run by Brigham and Women's Hospital 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 2 inclusion and 7 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 18 May 2023. 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. 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?
Yes. Results are posted in the registry (first posted 18 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Cue-induced Cravings and Anxiety After 3 Days of Cannabidiol Administration (time frame: pre-exposure (Visit 2, which is day 2 of the 5-day study) and post-exposure (Visit 3, which is day 5 of the 5-day study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04192370, which also lists 1 linked publication.
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 18 May 2023.