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Cannabinoid
Cannabidiol for Opioid Use Disorder and Chronic Pain
Phase < 1
Recruiting
Led By Joao De'Aquino, M.D.
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Having chronic pain, uniformly operationalized as grade II (high-intensity) non-cancer musculoskeletal pain for ≥ 6 months
Diagnosed with OUD and currently enrolled in methadone or buprenorphine maintenance treatment
Must not have
Current use benzodiazepines or platelet inhibitors (e.g., clopidogrel, apixaban, ticagrelor)
Current weight of less of 60 kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 weeks
Summary
This trial will test the effects of CBD on social anxiety.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects aren't listed here, CBD can commonly cause tiredness, diarrhea, changes in appetite/weight. Since it's being tested against saline (a harmless substance), any additional side effects observed could help understand CBD's impact.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had severe non-cancer related muscle or bone pain for 6 months or more.
Select...
I am diagnosed with opioid use disorder and am on methadone or buprenorphine.
Select...
I am not pregnant, not breastfeeding, and using birth control.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking benzodiazepines or medications like clopidogrel.
Select...
I weigh less than 60 kg.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Quantitative Sensory Testing (QST)
Systematic Assessment for Treatment Emergent Events (SAFTEE)
Trial Design
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
Find a Location
Who is running the clinical trial?
VA Connecticut Healthcare SystemFED
85 Previous Clinical Trials
8,760 Total Patients Enrolled
3 Trials studying Chronic Pain
320 Patients Enrolled for Chronic Pain
Yale UniversityLead Sponsor
1,926 Previous Clinical Trials
3,031,292 Total Patients Enrolled
16 Trials studying Chronic Pain
3,377 Patients Enrolled for Chronic Pain
National Institute on Drug Abuse (NIDA)NIH
2,592 Previous Clinical Trials
3,328,640 Total Patients Enrolled
64 Trials studying Chronic Pain
84,477 Patients Enrolled for Chronic Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have gone through significant emotional stress in the past 6 weeks, as decided by the main doctor in charge.I am between 18 and 70 years old, regardless of my veteran status.I am currently taking benzodiazepines or medications like clopidogrel.You have severe depression or are currently having thoughts of hurting yourself.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.I weigh less than 60 kg.I have had severe non-cancer related muscle or bone pain for 6 months or more.A doctor will decide if my use of THC or CBD affects my study participation.I am diagnosed with opioid use disorder and am on methadone or buprenorphine.I am not pregnant, not breastfeeding, and using birth control.I was in a psychiatric hospital within the last 2 months.
Research Study Groups:
This trial has the following groups:- Group 1: CBD 400mg
- Group 2: Saline
- Group 3: CBD 1200mg
- Group 4: CBD 800mg
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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