Cannabidiol for Addiction

(ACROS Trial)

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

Trial Summary

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.

What data supports the effectiveness of the drug Cannabidiol for addiction?

Research suggests that Cannabidiol (CBD) may help reduce the rewarding effects of addictive drugs like opioids and alcohol, potentially making it useful in addiction treatment. Studies have shown that CBD can decrease drug cravings and stress-related responses, which are important factors in preventing relapse. ^{1 2 3 4 5}

How is the drug cannabidiol different from other treatments for addiction?

Cannabidiol (CBD) is unique because it is a component of cannabis that does not cause a high and may reduce the rewarding effects of addictive drugs like cocaine and morphine. Unlike other treatments, CBD is being explored for its potential to decrease cravings and withdrawal symptoms without the risk of addiction itself. ^{1 3 4 6 7}

What is the purpose of this trial?

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). The first phase of this project was an open cross-over design study in healthy individuals to confirm the safety and pharmacokinetic (PK) effects of CBD (BSPG CBD; Brains Bioceutical). The second phase was a double-blinded randomized controlled trial to determine whether CBD reduces craving and anxiety in individuals with OUD maintained on opioid agonist therapy. This phase 3 trial will determine whether CBD can serve as a potential adjunct treatment to reduce illicit opioid use in individuals with OUD maintained on opioid agonist therapy.

Research Team

Yasmin Hurd, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Trials of Cannabidiol for Substance Use Disorders: Outcome Measures, Surrogate Endpoints, and Biomarkers. [2021]

2. Switzerland 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. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Effects of Cannabidiol on Morphine Conditioned Place Preference in Mice. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Cannabidiol and substance use disorder: Dream or reality. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Effects of cannabidiol plus naltrexone on motivation and ethanol consumption. [2021]

6. Argentina pubmed.ncbi.nlm.nih.gov

Cannabidiol pharmacotherapy for delta-9-tetrahidrocannabinol dependence [2022]

7. Brazil pubmed.ncbi.nlm.nih.gov

Cannabidiol for the treatment of crack-cocaine craving: an exploratory double-blind study. [2021]