CBD for Opioid Use Disorder

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

150 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a double-blind, placebo-controlled, parallel group study designed to assess the tolerability and efficacy of fsCBD and bsCBD, compared to a placebo control, to reduce opioid use, anxiety, and pain and improve sleep and cognitive function. If eligible for the study, subjects will be randomized to receive one of the conditions for 12 weeks.

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.

What data supports the effectiveness of this drug for opioid use disorder?

Preliminary studies suggest that cannabidiol (CBD) may help reduce craving and anxiety in individuals with heroin use disorder, which are key factors in addiction and relapse. Additionally, CBD has shown potential in managing craving and withdrawal symptoms in other substance use disorders, indicating it might be beneficial for opioid use disorder as well. ^{1 2 3 4 5}

Is CBD safe for humans?

CBD is generally considered safe for humans, but it can cause side effects like sleep disturbances, sedation, and infections. It may also interact with other medications, so it's important to be cautious if you're taking other drugs. ^{1 4 6 7 8}

How is the drug CBD unique for treating opioid use disorder?

CBD is unique for treating opioid use disorder because it may help reduce cravings and prevent relapse by affecting brain processes related to stress and reward, which are often involved in addiction. Unlike traditional treatments like buprenorphine, CBD is being explored as an additional option to help manage these cravings and reduce the likelihood of relapse. ^{2 3 4 9 10}

Eligibility Criteria

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.

I am 18 years old or older.

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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 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]

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]

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 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]

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]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

Cannabidiol for the treatment of crack-cocaine craving: an exploratory double-blind study. [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. Switzerland pubmed.ncbi.nlm.nih.gov

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

4. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and pharmacokinetics of oral cannabidiol when administered concomitantly with intravenous fentanyl in humans. [2018]

5. United States 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. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Cannabidiol as a Harm Reduction Strategy for People Who Use Drugs: A Rapid Review. [2023]

7. England pubmed.ncbi.nlm.nih.gov

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

8. Switzerland pubmed.ncbi.nlm.nih.gov

Potential Adverse Drug Events and Drug-Drug Interactions with Medical and Consumer Cannabidiol (CBD) Use. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Cannabidiol as a treatment for craving and relapse in individuals with cocaine use disorder: a randomized placebo-controlled trial. [2021]

10. United States 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. [2022]