CBD for Opioid Use Disorder

No longer recruiting at 1 trial location

Overseen By Raeghan Mueller

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Colorado, Denver

Must not be taking: Epidiolex interactors, Antiepileptics

Disqualifiers: Recreational drug use, Alcohol use, Unstable medical illness, Psychotic disorders, others

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

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of cannabidiol (CBD), a compound from the cannabis plant, to determine if it can help reduce opioid use, anxiety, and pain, while also improving sleep and brain function. Participants will receive either broad-spectrum CBD, full-spectrum CBD, or a placebo (an inactive substance) for 12 weeks. It suits individuals interested in trying CBD to reduce opioid use or ease pain, provided they are not using other recreational drugs or receiving treatment for severe medical conditions. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires you to stop taking certain medications, especially those that interact with Epidiolex or are used for epilepsy. If you're on any of these, you may need to stop them before joining the study.

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

Research has shown that cannabidiol (CBD) is generally safe for use. Studies have found that CBD does not increase the side effects of opioid drugs like fentanyl, suggesting it can be safely combined with opioids. One study found that both broad-spectrum CBD (without THC) and full-spectrum CBD (with a tiny amount of THC) are safe and may help reduce cravings and anxiety in people with opioid use disorder.

Both broad-spectrum and full-spectrum CBD have demonstrated similar safety levels. Many people using CBD report substituting it for pain medications like NSAIDs and opioids, suggesting it might offer benefits with fewer side effects.

This is a Phase 2 study, indicating that earlier trials have already shown CBD to be safe enough for continued testing in people. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike traditional treatments for opioid use disorder that often rely on medications like methadone or buprenorphine, these investigational treatments use cannabidiol (CBD) as the active ingredient. Researchers are exploring both broad-spectrum CBD, which contains 0% THC, and full-spectrum CBD, which contains less than 0.3% THC. The excitement stems from CBD's potential to manage cravings and withdrawal symptoms without the psychoactive effects associated with THC. This approach could offer a non-addictive alternative to current opioid dependence therapies, potentially enhancing recovery outcomes and reducing the risk of relapse.

What evidence suggests that this trial's treatments could be effective for opioid use disorder?

Research has shown that cannabidiol (CBD) may assist individuals with opioid use disorder. In this trial, participants will receive either broad-spectrum or full-spectrum CBD, or a placebo. Studies have found that both broad-spectrum and full-spectrum CBD can reduce opioid cravings and ease anxiety during withdrawal, which helps prevent relapse. CBD appears to influence brain functions related to stress and reward, potentially reducing cravings. Additionally, studies have shown that CBD is generally well-tolerated, with no signs of causing dependence or withdrawal. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

Adults with a desire to reduce pain or opioid use through cannabidiol (CBD) can join this study. Excluded are those using recreational drugs, heavy alcohol users, severe opioid addicts unless stable and approved by doctors, people treated for certain mental disorders within the last year, pregnant/nursing women not on birth control, and anyone with unstable medical conditions.

Inclusion Criteria

I want to use CBD to lessen my pain or reduce opioid use.

Exclusion Criteria

I am not taking medications that interact with Epidiolex and have no recent severe mental health issues.

I don't have any severe illnesses and if I had surgery recently, I am cleared by my doctor.

Self-reported recreational drug use (other than opioids) in the past 30 days or failed urine screen for cocaine, benzodiazepines (if not prescribed), MDMA, sedatives, or methamphetamine

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either fsCBD, bsCBD, or placebo for 12 weeks to assess reduction in opioid use, anxiety, and pain, and improvement in sleep and cognitive function

12 weeks

4 visits (in-person), weekly virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Cannabidiol
• Placebo

Trial Overview

The trial is testing two forms of CBD against a placebo to see if they help lower opioid use and relieve anxiety, pain while improving sleep and cognitive function. Participants will be randomly assigned one of these treatments for 12 weeks in a double-blind setup where neither they nor the researchers know who's getting what.

How Is the Trial Designed?

Group I: Broad-spectrum Cannabidiol Active Control 1 Intervention

210mg/day of broad-spectrum cannabidiol, containing 0%THC.

Group II: Full-spectrum Cannabidiol Active Control 1 Intervention

210mg/day of full-spectrum cannabidiol, containing less than 0.3%THC.

Group III: Hemp Seed Oil Placebo Placebo Group 1 Intervention

210mg/day of hemp-seed oil with no cannabinoids present.

Cannabidiol is already approved in United States, European Union, Canada 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

Approved in Canada as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Published Research Related to This Trial

In a small study of 5 participants with opioid use disorder (OUD) who were on buprenorphine treatment, CBD significantly reduced cue-induced craving from an average of 3.2 to 0.4 on a visual analog scale after 3 days of treatment.

CBD was well tolerated among participants, with only one case of moderate sedation reported, suggesting it may be a safe adjunctive treatment for reducing cravings in individuals with OUD on buprenorphine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol Effect on Cue-Induced Craving for Individuals with Opioid Use Disorder Treated with Buprenorphine: A Small Proof-of-Concept Open-Label Study. Suzuki, J., Martin, B., Prostko, S., et al.[2022]

A review of 27 studies, including 5 randomized trials, indicates that cannabidiol (CBD) may help reduce drug cravings and anxiety in individuals with opioid use disorder, suggesting its potential as a harm reduction tool.

While CBD shows promise in improving mood and well-being among people who use drugs, it is not sufficient as a standalone treatment and should be considered an adjunct to standard care, highlighting the need for further research on effective dosing and administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol as a Harm Reduction Strategy for People Who Use Drugs: A Rapid Review. Lo, LA., MacCallum, CA., Nanson, K., et al.[2023]

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]

Nearly 50% of CBD users experienced adverse drug events (ADEs), with common issues including elevated liver enzymes, sedation, and sleep disturbances, indicating a significant safety concern.

CBD has a high potential for drug-drug interactions (DDIs) due to its effects on drug metabolism, particularly with enzymes like CYP3A4 and CYP2C19, suggesting that careful monitoring and dose adjustments may be necessary for patients on multiple medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential Adverse Drug Events and Drug-Drug Interactions with Medical and Consumer Cannabidiol (CBD) Use. Brown, JD., Winterstein, AG.[2020]

In a double-blind randomized placebo-controlled trial involving drug-abstinent individuals with heroin use disorder, cannabidiol (CBD) significantly reduced cue-induced craving and anxiety, which are key factors in addiction relapse.

CBD not only had immediate effects but also showed lasting benefits, reducing craving and anxiety up to 7 days after treatment, without serious adverse effects, suggesting its potential as a nonopioid treatment for opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol for the Reduction of Cue-Induced Craving and Anxiety in Drug-Abstinent Individuals With Heroin Use Disorder: A Double-Blind Randomized Placebo-Controlled Trial. Hurd, YL., Spriggs, S., Alishayev, J., et al.[2020]

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]

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) 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 study involving 78 adults with moderate to severe cocaine use disorder, daily administration of 800 mg of cannabidiol (CBD) did not significantly reduce drug-cue-induced cravings compared to a placebo.

The study also found no difference in the time to relapse between participants taking CBD and those on placebo, indicating that CBD may not be an effective treatment for preventing relapse in cocaine use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol as a treatment for craving and relapse in individuals with cocaine use disorder: a randomized placebo-controlled trial. Mongeau-Pérusse, V., Brissette, S., Bruneau, J., 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]

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