Cannabidiol for Addiction

(ACROS Trial)

Recruiting at 1 trial location

Overseen By Jonathan Hupf

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Icahn School of Medicine at Mount Sinai

Must be taking: Opioid agonists

Must not be taking: Buproprion, rifampin, barbiturates, others

Disqualifiers: Non-English, Severe substance use, others

Stay on Your Current Meds You can continue your current medications while participating

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 4

Duration: 24 weeks

450 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether cannabidiol (CBD) can reduce cravings and prevent relapse in individuals with opioid use disorder (OUD) who are already receiving methadone or buprenorphine. Researchers are testing various CBD doses to determine if it can effectively complement existing treatments by reducing illicit opioid use. Individuals currently on methadone or buprenorphine treatment for at least 14 days and who have OUD or are in remission may be suitable candidates for this study. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial requires that participants stay on their current opioid agonist maintenance treatment with methadone or buprenorphine. However, you must not use any medications or supplements that interact with CBD within 14 days before starting the trial and during the 24-week treatment period.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that cannabidiol (CBD) is usually safe for use. However, some studies have reported side effects among participants. About 79% experienced issues, with 25% feeling sleepy and 11% having seizures. Other common problems included fatigue.

Despite these side effects, the World Health Organization states that CBD does not cause addiction or dependence. Concerns exist about its effects on the liver and interactions with other medications, but these are still under investigation. The FDA is also examining the safety of CBD products.

In summary, while CBD may help reduce cravings and anxiety, considering these possible side effects is important before deciding to join a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for opioid use disorder?

Unlike traditional treatments for addiction, which often involve medications like methadone or buprenorphine, cannabidiol (CBD) offers a potentially new approach. CBD is derived from cannabis but doesn't produce a high, making it a unique option for those seeking alternatives to opioid-based treatments. Researchers are excited about CBD because it may help reduce cravings and anxiety associated with addiction without the risk of dependency. Additionally, CBD's anti-inflammatory and neuroprotective properties could offer broader benefits for brain health and recovery.

What evidence suggests that cannabidiol could be an effective treatment for opioid use disorder?

Studies have shown mixed results regarding the use of cannabidiol (CBD) for treating substance use disorders. Research suggests that CBD alone is not very effective for these disorders. However, some studies indicate that CBD might reduce the pleasurable effects of substance abuse, potentially aiding recovery. There is no strong evidence yet that CBD alone can effectively treat opioid use disorder (OUD), but it is generally considered safe. This trial will test different dosages of CBD, with one group receiving 200 mg and another 400 mg, to explore its potential in reducing cravings and preventing relapse in people with OUD. Ongoing research continues to investigate whether CBD can help reduce cravings and prevent relapse in individuals with OUD. ^{4 6 7 8 9}

Who Is on the Research Team?

Yasmin Hurd, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for individuals with opioid use disorder (OUD) who are currently on opioid agonist therapy. It aims to see if cannabidiol (CBD) can help reduce the urge to use opioids and prevent relapse. The study excludes details about specific inclusion and exclusion criteria.

Inclusion Criteria

Current opioid use disorder (OUD) or OUD in remission while on maintenance therapy with OAT, as determined by DSM-5 with the M.I.N.I. interview (Mini-International Neuropsychiatric Interview)

I understand the study and can consent to participate.

I've been on methadone or buprenorphine for over 2 weeks and meet the dose requirements.

Exclusion Criteria

Participants who have been court mandated to attend treatment centers

Participants who are non-English speaking

Psychiatric conditions under DSM-5 (examined with the MINI) that would make study participation unsafe, or which would prevent adherence to study procedure

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 200 mg or 400 mg of CBD or placebo twice daily to assess its effects on opioid use disorder

24 weeks

Visits every 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cannabidiol

Trial Overview

The study tests whether CBD can be an effective additional treatment for reducing illicit opioid use among those already receiving standard therapy. Participants will either receive CBD or a placebo, decided randomly, in a double-blinded setup where neither they nor the researchers know who gets what until after the results.

How Is the Trial Designed?

Group I: 2 capsules CBD (400 mg) Experimental Treatment 1 Intervention

2 capsules 400 mg CBD 2x per day

Group II: 1 capsule CBD (200 mg) Experimental Treatment 1 Intervention

1 capsule 200 mg CBD 2x per day

Group III: 1 capsule placebo and 2 capsules placebo Placebo Group 1 Intervention

1 capsule 200 mg placebo 2x per day or 2 capsules 400 mg placebo 2x per day

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

International Center for Health Outcomes and Innovation Research

Collaborator

Trials

6

Recruited

970+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Brains Bioceutical

Collaborator

Published Research Related to This Trial

Current treatments for cannabis use disorders are not very effective, highlighting a significant health issue worldwide.

Preliminary evidence suggests that cannabidiol (CBD) may help reduce cannabis use, withdrawal symptoms, and cravings, but more extensive trials with larger patient groups and longer durations are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol pharmacotherapy for delta-9-tetrahidrocannabinol dependence Pavlovsky, F., Groisman, R., Hurtado, AK., et al.[2022]

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]

The combination of low doses of naltrexone and cannabidiol (CBD) significantly reduced alcohol consumption and motivation to drink in mice more effectively than either drug alone, suggesting a synergistic effect.

This enhanced efficacy is linked to changes in gene expression related to opioid and serotonin receptors, particularly the 5-HT1A receptor, indicating that these receptors play a crucial role in the mechanism of action for the drug combination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of cannabidiol plus naltrexone on motivation and ethanol consumption. Viudez-Martínez, A., García-Gutiérrez, MS., Fraguas-Sánchez, AI., 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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11986292/

Efficacy of cannabidiol alone or in combination with Δ‐9‐ ...

Conclusion. Cannabidiol (CBD) monotherapy does not appear to be efficacious for treatment of substance use disorders.

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health.harvard.edu

health.harvard.edu/blog/cannabidiol-cbd-what-we-know-and-what-we-dont-201808242496

Cannabidiol (CBD): What we know and what we don't

According to a report from the World Health Organization, "In humans, CBD exhibits no effects indicative of any abuse or dependence potential….

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7937926/

Clinical Trials of Cannabidiol for Substance Use Disorders

There is no published study demonstrating the efficacy of CBD alone to treat any substance use disorder. When choosing stringent inclusion ...

4.

harmreductionjournal.biomedcentral.com

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

Use and perceptions of Cannabidiol among individuals in ...

This study highlights a significant association between CBD usage and progressive views regarding CBD among individuals with OUD.

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0028390822000077

Cannabidiol and substance use disorder: Dream or reality

Taken together, these data indicate that CBD may be clinically useful in attenuating the rewarding effects of substance abuse. Thus, this review ...

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library.samhsa.gov/sites/default/files/pep22-06-04-003.pdf

Cannabidiol (CBD) – Potential Harms, Side Effects, and ...

Potential risks and harms associated with CBD use include adverse drug interactions, liver toxicity, and reproductive and developmental effects.

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About CBD | Cannabis and Public Health

Using CBD products is not risk free. The FDA has limited data on CBD safety. Please consider these possible side effects and risks before ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7052834/

Cannabidiol Adverse Effects and Toxicity - PMC

Of the 162 patients in the safety and tolerability analysis, 79% reported AEs, 25% somnolence, 11% convulsions, and more than 5% reported somnolence, fatigue, ...

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fda.gov

fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis

What to Know About Products Containing Cannabis and CBD

The FDA is working to answer questions about the science, safety, and quality of products containing cannabis and cannabis-derived compounds, particularly CBD.