40 Participants Needed

Cannabidiol for Opioid Use Disorder and Chronic Pain

JD
EM
JD
JM
Overseen ByJulia Meyerovich, M.S.
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Yale University
Must be taking: Methadone, Buprenorphine
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This is a double-blind, randomized, placebo-controlled cross-over human laboratory study with a duration of approximately 4 weeks, during which participants will come to the testing site for a total of five times: one initial screening session, and four experimental sessions where study medication, Cannabidiol (CBD) will be administered, separated by at least 72 hours to limit carryover effects.

Will I have to stop taking my current medications?

The trial requires that you stay on your current methadone or buprenorphine treatment. However, you cannot participate if you are currently using benzodiazepines or platelet inhibitors. The protocol does not specify other medication restrictions, so it's best to discuss your specific medications with the study team.

What data supports the effectiveness of the drug Cannabidiol (CBD) for Opioid Use Disorder and Chronic Pain?

Research shows that Cannabidiol (CBD) can reduce inflammation, as seen in studies where it was used to lower cytokine production (proteins that can cause inflammation) in response to various irritants. This suggests that CBD might help with conditions involving inflammation, which could be relevant for chronic pain management.12345

Is cannabidiol (CBD) safe for humans?

Research suggests that CBD is generally safe for humans, with studies showing it can be a non-intoxicating alternative to opioids for chronic pain. However, there are concerns about the risk of adulteration in freely available CBD products and potential health hazards for pregnant women.678910

How is the drug Cannabidiol (CBD) unique in treating opioid use disorder and chronic pain?

Cannabidiol (CBD) is unique because it is a non-intoxicating component of the cannabis plant that may help reduce opioid use and improve quality of life without the psychoactive effects associated with THC. Unlike traditional opioids, CBD has a better safety profile and may also improve sleep and reduce stress-related triggers for relapse in opioid use disorder.6791112

Research Team

JD

Joao De Aquino, M.D.

Principal Investigator

Yale University

Eligibility Criteria

This trial is for adults aged 18-70 with chronic high-intensity musculoskeletal pain and opioid use disorder, who are stable on opioid maintenance treatment. Participants must be able to consent in English, not have major medical issues or unstable psychiatric conditions, and women must not be pregnant or breastfeeding.

Inclusion Criteria

Capable of providing informed consent in English
You do not meet the criteria for having problems with drugs or alcohol, except for opioid use disorder or tobacco use disorder in the past year.
I have been on a stable dose of my opioid treatment for at least two weeks.
See 4 more

Exclusion Criteria

You have gone through significant emotional stress in the past 6 weeks, as decided by the main doctor in charge.
I am currently taking benzodiazepines or medications like clopidogrel.
You have severe depression or are currently having thoughts of hurting yourself.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 visit
1 visit (in-person)

Treatment

Participants receive oral CBD or placebo during four experimental sessions, with each session separated by at least 72 hours

4 weeks
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment via a phone call

1 week
1 visit (phone call)

Treatment Details

Interventions

  • Cannabidiol
Trial Overview The study tests the effects of Cannabidiol (CBD) at different doses (1200mg, 800mg, and 400mg) compared to a saline placebo in managing chronic pain and opioid dependency. It's a double-blind study where neither participants nor researchers know who gets CBD or placebo during four sessions after an initial screening.
Participant Groups
4Treatment groups
Active Control
Placebo Group
Group I: CBD 400mgActive Control1 Intervention
CBD 400 mg
Group II: CBD 1200mgActive Control1 Intervention
CBD 1200mg
Group III: CBD 800mgActive Control1 Intervention
CBD 800mg
Group IV: SalinePlacebo Group1 Intervention
saline

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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

VA Connecticut Healthcare System

Collaborator

Trials
86
Recruited
8,800+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Findings from Research

In a study of 48 patients with chronic beryllium disease (CBD) treated with inhaled corticosteroids (ICS), there was no significant change in pulmonary function over time compared to 68 untreated controls, indicating that ICS may not affect lung function decline.
However, ICS treatment led to significant improvements in symptoms such as cough (58% improvement) and dyspnea (26% improvement), particularly in patients with lower baseline lung function, suggesting that ICS can be beneficial for symptom management in CBD.
Effect of inhaled corticosteroids on lung function in chronic beryllium disease.Mroz, MM., Ferguson, JH., Faino, AV., et al.[2023]
The COMBO-MS trial is designed to compare the effectiveness of cognitive behavioral therapy (CBT), modafinil, and their combination in reducing fatigue in patients with multiple sclerosis (MS) over a 12-week period, involving random assignment of participants with significant fatigue.
The study aims to determine if combination therapy is more effective than either treatment alone and to explore how factors like depression, sleep disorders, and disease severity may influence treatment outcomes, which could lead to better management strategies for MS-related fatigue.
A randomized pragmatic trial of telephone-delivered cognitive behavioral-therapy, modafinil, and combination therapy of both for fatigue in multiple sclerosis: The design of the "COMBO-MS" trial.Kratz, AL., Alschuler, KN., Ehde, DM., et al.[2020]
In a post hoc analysis of the FORWARD study involving severe COPD patients, treatment with extrafine beclomethasone dipropionate plus formoterol fumarate (BDP-FF) resulted in a 35% reduction in exacerbation rates compared to treatment with formoterol fumarate alone.
The findings support the new GOLD 2017 recommendations, suggesting that inhaled corticosteroid (ICS) and long-acting β-agonist (LABA) therapy is a beneficial treatment option for COPD patients who experienced one exacerbation in the previous year.
The efficacy of extrafine beclomethasone dipropionate-formoterol fumarate in COPD patients who are not "frequent exacerbators": a post hoc analysis of the FORWARD study.Singh, D., Vezzoli, S., Petruzzelli, S., et al.[2018]

References

Effect of inhaled corticosteroids on lung function in chronic beryllium disease. [2023]
A randomized pragmatic trial of telephone-delivered cognitive behavioral-therapy, modafinil, and combination therapy of both for fatigue in multiple sclerosis: The design of the "COMBO-MS" trial. [2020]
The efficacy of extrafine beclomethasone dipropionate-formoterol fumarate in COPD patients who are not "frequent exacerbators": a post hoc analysis of the FORWARD study. [2018]
A systematic review of cannabidiol dosing in clinical populations. [2023]
Oral inhalation of cannabidiol delivered from a metered dose inhaler to alleviate cytokine production induced by SARS-CoV-2 and pollutants. [2022]
Efficacy, Safety, and Regulation of Cannabidiol on Chronic Pain: A Systematic Review. [2022]
Safety and pharmacokinetics of oral cannabidiol when administered concomitantly with intravenous fentanyl in humans. [2018]
Tolerability and Efficacy of a 10:25 Preparation of Δ9-Tetrahydrocannabinol and Cannabidiol for Treatment of Chronic Back or Neck Pain: A Multiple-Dose Escalation Study. [2023]
Evaluation of the effects of CBD hemp extract on opioid use and quality of life indicators in chronic pain patients: a prospective cohort study. [2020]
A Balanced Approach for Cannabidiol Use in Chronic Pain. [2021]
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]
12.United Statespubmed.ncbi.nlm.nih.gov
The Role of Cannabidiol (CBD) in Chronic Pain Management: An Assessment of Current Evidence. [2020]