CompletedPhase 2

Cannabidiol in the Treatment of Opioid Use Disorder

United States76 participantsStarted 2023-10-04

Plain-language summary

The long-term goal of the project is to determine whether cannabidiol (CBD) can reduce craving and relapse in individuals with opioid use disorder (OUD). The first phase of our project was an open cross-over design study in healthy individuals to confirm the safety and pharmacokinetic (PK) effects of CBD. This next phase is to determine whether CBD can serve as a potential adjunct treatment to reduce craving and anxiety in individuals with OUD maintained on opioid agonist therapy.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

INCLUSION CRITERIA: An individual who meets all of the following criteria will be eligible for study participation: * Individuals between 18 and 65 years old * Ability to understand and give informed consent. * Current opioid use disorder (OUD) or OUD in remission while on maintenance therapy with OAT, as determined by DSM-5 with the M.I.N.I. interview (Mini-International Neuropsychiatric Interview). * Current opioid agonist maintenance treatment in an opioid treatment program with methadone or buprenorphine for at least 14 days prior to study participation. With the following more specific criteria for each of these two medications: * Current methadone maintenance treatment with a dose of ≥ 40mg/day, (maximum: 200mg/day), AND urinary toxicology positive for methadone and EDDP; OR * Current buprenorphine maintenance treatment with a dose of ≥ 8mg/day (maximum: 24mg/day), AND urinary toxicology positive for buprenorphine. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation: * Participants who are non-English speaking. * Psychiatric conditions under DSM-5 (examined with the MINI) that would make study participation unsafe or which would prevent adherence to study procedure; examples include: suicidal or homicidal ideation requiring immediate attention, inadequately-treated mental health disorder (e.g., active psychosis, uncontrolled bipolar disorder). * Current diagnosis of a severe substance use disorder (exce…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial used cannabidiol — CBD — to try to reduce opioid cravings and anxiety in people with opioid use disorder, and it's now completed — so has the results data been published yet, and what did it show about whether CBD actually helped?
2Since this was a Phase 2 trial, it was mainly designed to get early evidence on safety and whether CBD shows promise — does that mean we don't yet have the kind of large-scale proof needed to know if it works as well as established treatments like buprenorphine or methadone?
3The trial tracked urine drug tests as one of its main measures — based on what's known so far from studies like this one, how does CBD compare to standard medication-assisted treatment when it comes to actually reducing opioid use?
4The researchers used a formal safety checklist called the SAFTEE to track side effects — do you know if any concerning safety signals came up in this trial that I should factor into any conversation about CBD as part of my care?
5Given that this trial measured anxiety alongside cravings, and anxiety can be a big part of opioid withdrawal and recovery, is there anything from this research that might be relevant to my specific situation and worth discussing as part of a broader treatment plan?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Visual Analog Scale for Craving (VASC)

Timeframe: Baseline and 4 weeks

Change in Visual Analog Scale Anxiety (VASA)

Timeframe: Baseline and 4-weeks

Percentage of Participants With Positive Urine Toxicology

Timeframe: 4-weeks

Systematic Assessment for Treatment Emergent Events (SAFTEE)

Timeframe: weekly for 8 weeks (Baseline, Week 1, 2, 3, 4, 5, 6, 7, and 8)

Trial details

NCT IDNCT06206291

SponsorYasmin Hurd

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-04

Results submitted2026-04-02

View on ClinicalTrials.gov More Opioid Use Disorder trials