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New treatment option for Chronic Pain
Official title Cannabidiol in Opioid Use Disorder and Chronic Pain
ClinicalTrials.gov ID: NCT04587791
What this study is testing
What is 400 mg Cannabidiol?
400 mg Cannabidiol is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic pain.
Also referred to as CBD, Epidiolex.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a randomized, placebo-controlled, crossover human laboratory study investigating the dose-dependent safety and acute effects of Cannabidiol (CBD) on measures of pain and opioid craving in outpatients with opioid use disorder (OUD) receiving medication-assisted treatment with methadone or buprenorphine. With a duration of approximately 4 weeks, participants will come to the testing site for a total of five times: one initial screening session, and four experimental sessions where study medication, CBD, will be administered, separated by at least 72 hours to limit carryover effects.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Males and females, Veterans and non-Veterans, aged between 18 and 70 years old.
- Diagnosed with OUD and currently enrolled in methadone or buprenorphine maintenance treatment.
- Having chronic pain, uniformly operationalized as grade II (high-intensity) non-cancer pain for ≥ 6 months.
- Capable of providing informed consent in English.
- Compliant in opioid maintenance treatment and on a stable dose for four weeks or longer.
You likely can't join if
- Other current major psychiatric disorders deemed clinically unstable by the principal investigator, such as severe depression and/or active suicidal...
- Having experienced major psychosocial stressors recently (≤ 6 weeks before enrollment), at the discretion of the principal investigator.
- Methadone dose under 30 mg or over 150 mg/day.
- Buprenorphine dose over 24 mg per day.
- Having received inpatient psychiatric treatment recently (≤ 60 days before enrollment).
- Candidates receiving products containing either THC or CBD will be excluded. All participants will be asked to abstain from cannabinoids. Prior to...
See the full eligibility criteria
- Males and females, Veterans and non-Veterans, aged between 18 and 70 years old.
- Diagnosed with OUD and currently enrolled in methadone or buprenorphine maintenance treatment.
- Having chronic pain, uniformly operationalized as grade II (high-intensity) non-cancer pain for ≥ 6 months.
- Capable of providing informed consent in English.
- Compliant in opioid maintenance treatment and on a stable dose for four weeks or longer.
- Not meeting DSM-5 criteria for substance use disorders other than OUD or tobacco use disorder within the last 12 months.
- No current medical problems deemed contraindicated for participation by principal investigator.
- For women, not pregnant as determined by pregnancy screening; not breast-feeding; using acceptable birth control methods. Acceptable contraception for females includes oral contraceptives, contraceptive depot...
- Other current major psychiatric disorders deemed clinically unstable by the principal investigator, such as severe depression and/or active suicidal ideation.
- Having experienced major psychosocial stressors recently (≤ 6 weeks before enrollment), at the discretion of the principal investigator.
- Methadone dose under 30 mg or over 150 mg/day.
- Buprenorphine dose over 24 mg per day.
- Having received inpatient psychiatric treatment recently (≤ 60 days before enrollment).
- Candidates receiving products containing either THC or CBD will be excluded. All participants will be asked to abstain from cannabinoids. Prior to receiving the study medication on the first test session, participants'...
- A physician will carefully evaluate participants for use of over-the-counter or prescription psychoactive drugs known to affect pain threshold or pain tolerance (including NSAIDS, serotonin-norepinephrine reuptake...
- Current, regular use of benzodiazepines, other prescription opioids, or platelet inhibitors (e.g., clopidogrel, apixaban, ticagrelor).
- Current weight of less of 60 kg.
- Allergy to sesame seed oil, which is an ingredient of the CBD formulation used.
- Serious medical or neurological illness or treatment for a medical disorder that could interfere with study participation as determined by principal investigator.
- Participants who have elevation of liver enzymes (ALT and/or AST) 2x above the normal limit or higher.
- Contraindications for exposure to cold temperatures, such as Raynaud's phenomenon and hypertension.
The study team makes the final eligibility decision.
Where it's taking place
- West Haven, Connecticut, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include West Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.