Cannabidiol for Opioid Use Disorder and Chronic Pain
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?
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive oral CBD or placebo during four experimental sessions, with each session separated by at least 72 hours
Follow-up
Participants are monitored for safety and effectiveness after treatment via a phone call
Treatment Details
Interventions
- Cannabidiol
Cannabidiol is already approved in United States, European Union, Canada for the following indications:
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome
- Seizures associated with tuberous sclerosis complex
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome
- Seizures associated with tuberous sclerosis complex
- 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
VA Connecticut Healthcare System
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator