CBD for Opioid Use Disorder

Overseen By Ashanta Carter

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Yasmin Hurd

Must be taking: Methadone

Disqualifiers: Non-English, Cardiac disease, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how CBD, a compound from cannabis, might help people with opioid use disorder by reducing cravings and anxiety. Participants will receive either CBD or a placebo (an inactive substance) to compare effects. Researchers will use brain imaging to observe how CBD affects brain activity. The trial seeks individuals who have been on methadone for opioid use disorder for at least two weeks and are experiencing cravings or anxiety related to their condition. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be on a stable dose of methadone for at least 14 days before participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that CBD (cannabidiol) is generally safe for people with opioid use disorder (OUD). In past studies, CBD helped reduce cravings and anxiety without causing major side effects. One study focused on safety found that any negative effects were minor and manageable, suggesting that CBD is safe in this context.

This trial is in an early stage, so the researchers are closely monitoring its safety. However, the existing research provides a positive view of CBD's safety for those considering joining a clinical trial for OUD treatment. ^{1 2 3 4}

Why do researchers think this study treatment might be promising?

Researchers are excited about using Cannabidiol (CBD) for opioid use disorder because it offers a new approach compared to traditional treatments like methadone or buprenorphine. Unlike these standard options, CBD is a non-psychoactive compound derived from the cannabis plant, which means it doesn't produce the "high" associated with cannabis. CBD may help reduce cravings and anxiety, two major challenges in opioid recovery. This unique mechanism of action could provide a safer and less addictive alternative for managing opioid dependence.

What evidence suggests that CBD might be an effective treatment for opioid use disorder?

Research has shown that CBD (cannabidiol), which participants in this trial may receive, might help reduce cravings and anxiety in people with opioid use disorder. A review of studies found that CBD effectively lowered opioid cravings and anxiety related to quitting. Some people already use CBD to help manage their addiction, suggesting it can be a useful tool. Another study found that more than half of chronic pain patients reduced or stopped their opioid use after adding CBD to their routine. However, CBD alone might not be enough to handle withdrawal symptoms, so more research is needed. Overall, evidence suggests CBD could benefit those dealing with opioid use disorder. Participants in this trial will receive either CBD or a placebo to compare and validate the results. ^{1 2 3 5 6}

Who Is on the Research Team?

Yasmin Hurd

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with opioid use disorder, currently on methadone maintenance. Participants must have been abstinent from heroin for at least 7 days and cannot be seeking treatment for heroin addiction. They should not have other substance use disorders (except nicotine), be pregnant or breastfeeding, or have certain medical conditions that exclude them from MRI scans.

Inclusion Criteria

Urinary toxicology positive for methadone

I have been on methadone treatment of 40mg or more for over 14 days and have take-home doses.

Current opioid use disorder as determined by the M.I.N.I. interview (Mini-International Neuropsychiatric Interview)

Exclusion Criteria

I am experiencing withdrawal symptoms from opioids.

I am not using any reliable birth control methods.

My kidney function or liver enzymes have never been more than twice the normal limit.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive CBD or placebo for 3 daily doses with neuroimaging conducted immediately after the first dose and one week after the last dose

2 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of adverse events and changes in craving and anxiety

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Cannabidiol (CBD)
• Placebo

Trial Overview The study tests the effects of CBD versus a placebo in reducing craving and anxiety in individuals with opioid use disorder on methadone. It involves neuroimaging to observe brain activity after initial and repeated doses of CBD (800mg) over a week.

How Is the Trial Designed?

Group I: CBD 800mg Experimental Treatment 1 Intervention

Participants in Arm CBD 800 mg will receive 800mg of Cannabidiol in each of the three test sessions

Group II: Control Placebo Group 1 Intervention

Participants will receive a harmless, inactive solution to compare and validate the results of the other arms of the study

Cannabidiol (CBD) is already approved in United States, European Union for the following indications:

Approved in United States as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome
• Seizures associated with tuberous sclerosis complex

Approved in European Union as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome
• Seizures associated with tuberous sclerosis complex

Who Is Running the Clinical Trial?

Yasmin Hurd

Lead Sponsor

Trials

2

Recruited

200+

Hurd,Yasmin, Ph.D.

Lead Sponsor

Trials

6

Recruited

320+

GW Research Ltd

Industry Sponsor

Trials

36

Recruited

3,200+

Jazz Pharmaceuticals

Industry Sponsor

Trials

252

Recruited

35,100+

Bruce C. Cozadd

Jazz Pharmaceuticals

Chief Executive Officer since 2009

BA in Economics from Yale University, MBA from Stanford University

Dr. Austin

Jazz Pharmaceuticals

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

Published Research Related to This Trial

A study involving healthy volunteers showed that cannabidiol (CBD) can be safely administered alongside high-potency opioids like fentanyl without causing respiratory depression or cardiovascular issues, indicating its potential safety for further research.

The pharmacokinetics of CBD were consistent, with peak plasma concentrations occurring within a few hours after administration, suggesting that CBD does not interfere with the effects of opioids, laying the groundwork for exploring CBD as a treatment for opioid addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and pharmacokinetics of oral cannabidiol when administered concomitantly with intravenous fentanyl in humans. Manini, AF., Yiannoulos, G., Bergamaschi, MM., et al.[2018]

A review of 207 studies identified only 3 randomized clinical trials (RCTs) specifically focused on using cannabidiol (CBD) for cannabis use disorder, highlighting a significant gap in research for CBD's efficacy in treating substance use disorders.

Ongoing trials are enhancing outcome measures by incorporating peripheral biomarkers from the endocannabinoid system, which may help predict how well individuals respond to CBD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Trials of Cannabidiol for Substance Use Disorders: Outcome Measures, Surrogate Endpoints, and Biomarkers. Morel, A., Lebard, P., Dereux, A., et al.[2021]

Cannabidiol (CBD), specifically in its oral formulation Epidiolex, has been shown to have very low abuse potential and is unlikely to cause physical dependence, as demonstrated by studies in rats and nonhuman primates that showed no significant self-administration or withdrawal signs after chronic treatment.

The pharmacokinetic studies confirmed that the doses used in the experiments resulted in therapeutically relevant plasma levels, supporting the safety and efficacy of CBD for treating seizures in severe forms of epilepsy without the risks associated with addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preclinical Assessment of the Abuse Potential of Purified Botanical Cannabidiol: Self-Administration, Drug Discrimination, and Physical Dependence. Gray, RA., Heal, DJ., Maguire, DR., et al.[2022]

In a trial involving 31 men with crack-cocaine dependence, treatment with 300 mg/day of cannabidiol (CBD) for 10 days did not significantly reduce craving levels compared to a placebo, indicating limited efficacy in managing withdrawal symptoms.

Despite a successful craving induction technique, there were no significant differences in anxiety, depression, or sleep alterations between the CBD and placebo groups, suggesting that CBD may not effectively address these symptoms in crack-cocaine withdrawal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol for the treatment of crack-cocaine craving: an exploratory double-blind study. Meneses-Gaya, C., Crippa, JA., Hallak, JE., et al.[2021]

Cannabidiol (CBD) is a non-psychoactive compound from cannabis that can counteract the psychotropic effects of THC and has gained popularity in various therapeutic products, especially after the FDA approved Epidiolex® for treating severe epilepsy in children.

Despite its therapeutic potential, there is a lack of consistent international regulations governing the marketing and authorization of CBD products, which raises concerns about product safety and efficacy for consumers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacology and legal status of cannabidiol. Brunetti, P., Lo Faro, AF., Pirani, F., et al.[2021]

In a study involving 18 participants, vaporized CBD-dominant cannabis produced the highest blood concentration of CBD (171.1 ng/mL), significantly more than both vaporized CBD (104.6 ng/mL) and oral CBD formulations (13.7 ng/mL).

The study found that CBD alone does not convert to ∆9-THC, as ∆9-THC was only detected in participants using vaporized CBD-dominant cannabis, indicating that CBD-only products are unlikely to result in positive drug tests for THC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetic Profile of ∆9-Tetrahydrocannabinol, Cannabidiol and Metabolites in Blood following Vaporization and Oral Ingestion of Cannabidiol Products. Bergeria, CL., Spindle, TR., Cone, EJ., et al.[2023]

Cannabidiol (CBD) shows promise as a potential treatment for substance use disorders (SUD) due to its ability to regulate the reinforcing and motivational effects of various drugs of abuse, supported by both preclinical and clinical evidence.

CBD has a strong safety profile, lacks reinforcing properties, and is already present in approved medications like Sativex® and Epidiolex®, making it a viable candidate for further research and clinical trials in the management of SUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Cannabidiol in the Therapeutic Intervention for Substance Use Disorders. Navarrete, F., García-Gutiérrez, MS., Gasparyan, A., et al.[2021]

Cannabidiol (CBD) has shown promise in preclinical and clinical studies for its ability to inhibit the rewarding effects of addictive substances like cocaine, methamphetamine, and opioids, suggesting its potential as a treatment for substance use disorders.

Despite the encouraging evidence supporting CBD's efficacy in reducing drug addiction behaviors, further research is necessary to fully establish its therapeutic role in addiction treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol and substance use disorder: Dream or reality. Karimi-Haghighi, S., Razavi, Y., Iezzi, D., et al.[2023]

A pilot study involving 10 participants with opioid use disorder (OUD) found that a single dose of 600 mg of cannabidiol (CBD) significantly reduced cue-induced craving and attentional bias towards drug-related cues, suggesting it may help in preventing relapse.

These results indicate that CBD could be a promising adjunctive treatment to medications for OUD, like buprenorphine or methadone, by potentially lowering the brain's response to drug-related triggers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of cannabidiol on reward- and stress-related neurocognitive processes among individuals with opioid use disorder: A pilot, double-blind, placebo-controlled, randomized cross-over trial. Suzuki, J., Prostko, S., Szpak, V., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12104536/

The Potential Use of Cannabidiol in the Treatment of Opioid ... This systematic review found that CBD may reduce opioid cravings and abstinence‐related anxiety in individuals with opioid use disorder.

2. harmreductionjournal.biomedcentral.com harmreductionjournal.biomedcentral.com/articles/10.1186/s12954-024-01051-5

Use and perceptions of Cannabidiol among individuals in ... Our findings show that some individuals in treatment for OUD are already using CBD as a harm reduction intervention to control their addiction ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04587791

Cannabidiol in Opioid Use Disorder and Chronic Pain This is a double-blind, randomized, placebo-controlled cross-over human laboratory study with a duration of approximately 4 weeks, during which participants ...

4. tandfonline.com tandfonline.com/doi/full/10.1080/00325481.2019.1685298

Evaluation of the effects of CBD hemp extract on opioid use ... Results: Over half of chronic pain patients (53%) reduced or eliminated their opioids within 8 weeks after adding CBD-rich hemp extract to their ...

5. biorxiv.org biorxiv.org/content/10.1101/2025.10.08.680984v1

Effects of oral cannabidiol (CBD) on spontaneous opioid ... These data indicate that CBD alone may have limited effectiveness for treating opioid withdrawal. Reports of improved withdrawal symptoms ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06206291

Cannabidiol in the Treatment of Opioid Use Disorder The long-term goal of the project is to determine whether cannabidiol (CBD) can reduce craving and relapse in individuals with opioid use disorder (OUD).