Opioid Use DisorderPhase 2NCT06206291

Cannabidiol in the Treatment of Opioid Use Disorder

A Phase 2 study testing Cannabidiol (CBD) 200mg and Cannabidiol (CBD) 400mg in people with Opioid Use Disorder, run by Yasmin Hurd at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Opioid Use Disorder
What is being tested?: Cannabidiol (CBD) 200mg and Cannabidiol (CBD) 400mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 76 participants
Where: 1 siteUnited States
Study dates: 4 Oct 2023to 4 Apr 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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 (except for opioid and nicotine/tobacco) in the past 3 months, based on the MINI interview, that would preclude safe participation in the study as determined by the study medical clinician.
Alcohol intoxication when arriving at the study site (i.e., positive alcohol breathalyzer / alcohol salivary strips / urine alcohol).
Signs of acute drug intoxication when arriving at the study site as determined by clinician assessment.

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Medical or psychiatric contraindications for CBD administration (e.g., history of hypersensitivity to cannabinoids); or any of the ingredients in the product (gelatin or sesame oil).
Showing signs of acute opioid withdrawal symptoms (as determined by the result of the Clinical Opiate Withdrawal Scale (COWS). A Score of ≥ 5 or as interpreted by the investigator will be considered a positive result for withdrawal symptoms).
Have a medical condition that would make study participation unsafe, which would make treatment compliance difficult, or would prevent adherence to study procedure. This includes, but is not limited to the following criteria:
History of impaired renal function or elevated liver enzymes at prescreening. The exclusionary lab values are: >4x the upper limit of normal (ULN) per laboratory criteria for AST or ALT, >1.5x ULN for bilirubin or <30mL/min/1.73m2 eGFR
QTc Frederica > 500ms
Participating in another pharmacotherapeutic trial in the past 3 months.
Participants who have used any medication, dietary supplements (and/or grapefruit juice), or combination of medications and supplements known to alter the metabolism of, or interact with CBD (buproprion, rifampin, barbiturates, phenothiazines, cimetidine, etc.) 14 days prior to and during the duration of the study
For women: being pregnant (positive urine test for pregnancy) or breastfeeding.
Not using an appropriate method of contraception such as hormonal contraception (oral hormonal contraceptives, Depo-Provera, Nuva-Ring), intrauterine device (IUD), sterilization, or double barrier method (combination of any two barrier methods used simultaneously, i.e. condom, spermicide, diaphragm).
Participants who have been court mandated to attend treatment centers.

Trial locations and contacts

1 site in 1 country.

United States1 site

Icahn School of Medicine at Mount Sinai
New York, New York, 10029

Other trials in United States

About this study

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.

Read the detailed description

In this Phase 2 study, the research team will conduct a double-blind (placebo-controlled) randomized controlled trial to evaluate whether 200mg and/or 400mg CBD (BSPG Laboratories) given twice daily (morning and evening), as compared to placebo, reduces cue-induced craving and anxiety in individuals with opioid use disorder who are maintained on methadone or buprenorphine. In addition to in-lab physiological and behavioral assessments of cue-induced craving and anxiety, the research team will also employ ecological momentary assessment to obtain real-world measures of symptoms including craving, anxiety, and mood.

Conditions: Opioid Use Disorder
Being tested: Placebo, Cannabidiol (CBD) 200mg, Cannabidiol (CBD) 400mg
Keywords: CBD, Cannabidiol, Methadone, Buprenorphine, Opioid Use Disorder, OUD
Medical subject headings: Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
Matching placebo twice daily for first 4 weeks
Cannabidiol (CBD) 200mgDrug
First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.
Cannabidiol (CBD) 400mgDrug
Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.

Study groups in NCT06206291
Study group	Role	What they receive
Methadone CBD	Active comparator	CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks. Receives: Drug: Cannabidiol (CBD) 200mg; Drug: Cannabidiol (CBD) 400mg
Methadone Placebo	Placebo comparator	Matching placebo.in first dosing period and CBD 400mg in second dosing period Receives: Drug: Placebo; Drug: Cannabidiol (CBD) 400mg
Buprenorphine CBD	Active comparator	CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks. Receives: Drug: Cannabidiol (CBD) 200mg; Drug: Cannabidiol (CBD) 400mg
Buprenorphine Placebo	Placebo comparator	Matching placebo.in first dosing period and CBD 400mg in second dosing period Receives: Drug: Placebo; Drug: Cannabidiol (CBD) 400mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Visual Analog Scale for Craving (VASC)
Cue-induced Visual Analog Scale for craving is used to measure subjective craving responses to a drug and neutral video cues evaluated in the clinic. Changes in craving from baseline (pre-cue to post-cue and pre-neutral cue to post-neutral cue) will be measured and compared. Total scale ranges from 0-10, with higher scores indicating extreme cravings.
Measured: Baseline and 4 weeks
Change in Visual Analog Scale Anxiety (VASA)
Cue-induced Visual Analog Scale Anxiety is used to measure subjective anxiety responses to a drug and neutral video cue evaluated in the clinic. Changes in anxiety from baseline (pre-cue to post-cue and pre-neutral cue to post-neutral cue) will be measured and compared. Total scale from 0-10, with higher score indicating extreme anxiety.
Measured: Baseline and 4-weeks
Percentage of Participants With Positive Urine Toxicology
Percentage of participants with positive urine toxicology for illicit opioid use at 4 weeks.
Measured: 4-weeks
Systematic Assessment for Treatment Emergent Events (SAFTEE)
Systematic Assessment for Treatment Emergent Events (SAFTEE) is used to measure safety and tolerability. SAFTEE is a side effect self-report assessment scale that consists of 56 potential side effects. Participants rate how bothersome each side effect is on a scale of "none" (0), "mild" (1), "moderate" (2), "severe" (3). Total score ranges 0 - 168, higher scores indicate a higher level of side effect burden.
Measured: weekly for 8 weeks (Baseline, Week 1, 2, 3, 4, 5, 6, 7, and 8)

Secondary outcomes (24)

Change in Visual Analog Scale for Craving (VASC)
Cue-induced Visual Analog Scale for craving is used to measure subjective craving responses to a drug and neutral video cues evaluated in the clinic. Changes in craving at 8 weeks as compared to 4 weeks (pre-cue to post-cue and pre-neutral cue to post-neutral cue) will be measured and compared. Scale range: 0 (no craving) - 10 (extreme craving). Higher score indicates more extreme craving.
Measured: 4-weeks and 8-weeks
Change in Visual Analog Scale Anxiety (VASA)
Cue-induced Visual Analog Scale Anxiety is used to measure subjective anxiety responses to a drug and neutral video cue evaluated in the clinic. Changes in anxiety at 8 weeks as compared to 4 weeks (pre-cue to post-cue and pre-neutral cue to post-neutral cue) will be measured and compared. Scale: 0 (not at all anxious) - 10 (extremely anxious). Higher score indicates more extreme anxiety.
Measured: 4-weeks and 8-weeks
Change in Percentage of Participants With Positive Urine Toxicology
Proportion of percentage with positive urine toxicology for illicit opioid use at 8 weeks as compared to 4 weeks.
Measured: 4 weeks and 8 weeks
Change in Heroin Craving Questionnaire Short Form (HCQ-SF-14)
Heroin Craving Questionnaire Short Form (HCQ-SF-14): A 15 minute, 14 item self-administered to measure general heroin craving. Each item is rated on a 7-point Likert scale (1= strongly disagree, 7= strongly agree). Full scale ranges from 14-98, with higher scores indicating more severe heroin craving.
Measured: baseline and 4-weeks, 4-weeks and 8-weeks
Change in Generalized Anxiety Disorder Scale (GAD-7)
The General Anxiety Disorder 7-item questionnaire (GAD-7) assesses seven problem items potentially experienced over the past two weeks from "0" (not at all) to "3" (nearly every day). Individuals rank their levels of nervousness, anxiousness, relaxing, restlessness, irritability and fearfulness. Full scale from 0-21, with higher score indicating more anxiety symptoms.
Measured: Baseline and 4-weeks, 4-weeks and 8-weeks
Duration of Participant First Illicit Opioid Abstinence
Measured: any time during study, 8 weeks
Change in Patient Health Questionnaire (PHQ-9)
The Questionnaire Type 9 for Depression (PHQ-9) measures depression severity with the nine DSM-IV criteria scored as "0" (not at all) to "3" (nearly every day). Full scale ranges from 0-27, with higher score indicating more severe symptoms.
Measured: baseline and 4-weeks, 4-weeks and 8-weeks
Positive and Negative Affect Schedule (PANAS-SF)
A 20 item self-administered questionnaire evaluating current positive and negative affect. Each item is rated on a 5-point scale (0= Very slightly or not at all, 5= Extremely). Scores range from 10 - 50 for both sets of items. For the total positive score, a higher score indicates more of a positive affect. For the total negative score, a lower score indicates less of a negative affect.
Measured: baseline, 4-weeks and 8-weeks, post-cue collected within 10 minutes of pre-cue
Change in Heart Rate
Heart rate (beats/min) will be monitored throughout the time course of the study and change at Week 8 from baseline will be studied.
Measured: baseline and 8-weeks
Change in Blood Pressure
Blood pressure (in mmHg) will be monitored throughout the time course of the study and changes at week 8 as compared from baseline will be studied. Both diastolic and systolic pressures will be assessed.
Measured: baseline and 8-weeks
Change in Body Temperature
Body temperature (in degrees Fahrenheit) will be monitored throughout the time course of the study and changes at week 8 from baseline will be studied.
Measured: baseline and 8-weeks
Change in Oxygen Level
Oxygen level will be measured by pulse oximetry when vitals are collected. Change in oxygen level at week 8 as compared to baseline
Measured: baseline and 8-weeks
Change in Cue-induced Salivary Cortisol Levels
Study participant will chew on a cotton swab providing a saliva sample from which free cortisol levels will be measured as an indicator of stress response in association with video cues. Thus, the stress of craving will be monitored and measured to observe any neutral cue induced changes from between baseline and 4 weeks, and between 4 weeks and 8 weeks.
Measured: Baseline and 4-weeks, 4-weeks and 8-weeks
Sleep Duration in Minutes Per Night
Average sleep duration measured across 8 weeks.
Measured: up to 8-weeks
Change in Insomnia Severity Index (ISI)
A 5-10 minute, 7 question self-administered screening tool for insomnia. Each item rates the nature and symptoms of potential sleep problems using a 5-point Likert-type scale. Minimum score of 0 and maximum score of 28, with the highest score indicating prevalence and severity of insomnia.
Measured: baseline and 8-weeks
Change in The Digit Span Test Subtest of the Wechsler Adult Intelligence Scale 4th Edition
A 10-15 minute 30-item assessment that includes Digit Span Forward (DSF) and Digit Span Backward (DSB). DSF measures short-term memory, not working memory. DSB measures auditory working memory. Full scale from a minimum score of 0 and maximum score of 30, with the highest score indicating the total number of points achieved for correct responses.
Measured: baseline and 8-weeks
Change in The Symptom Check List 90 (SCL-90)
The Symptom Check List 90 (SCL-90): A 12-15 minute, 90 item self-administered psychometric instrument yielding nine scores of primary symptom dimensions (5-point rating scale; 1= Not at all, 5= Extremely), along with three scores based on global distress measures. Full scale ranges from a minimum score of 90 and maximum score of 450, with higher scores indicating more severe psychological distress.
Measured: baseline and 8-weeks
Change in Percentage of Participants With THC Positive in Urine.
Change in percentage of participants with THC positive in Urine - Substance use other than opioids measured in urine.
Measured: baseline and 4-weeks, 4-weeks and 8 weeks
Change in Plasma Level of THC Positive in Blood.
Change in plasma level THC Positive in - Substance use other than opioids measured in blood.
Measured: baseline and 4-weeks, 4-weeks and 8 weeks
Change in Concentration of Methadone Metabolites in Blood
Concentration of methadone metabolites measured in blood.
Measured: baseline and 4-weeks, 4-weeks and 8-weeks
Change in Concentration of Buprenorphine Metabolites in Blood
Concentration of buprenorphine metabolites measured in blood.
Measured: baseline and 4-weeks, 4-weeks and 8 weeks
Number of Participants Remaining in Treatment
Retention in treatment as measured by number of participants remaining in treatment.
Measured: up to 8 weeks
Change Methadone Dosage of Opioid Agonist Treatment
Change in the methadone dosage at Week 8 as compared to baseline.
Measured: baseline and 8 weeks
Number of CBD-COOH Positive Blood Toxicology
The number of CBD-COOH positive blood toxicology to measure adherence
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Oct 20234 Apr 2024

First posted16 Jan 2024
Study start4 Oct 2023
Primary completion4 Apr 2024
Study completion4 Apr 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06206291
Sponsor's protocol ID: STUDY-21-00607
Other IDs: GCO# 21-0663
Status last verified: May 2026
First submitted: 4 Jan 2024
Last updated: 18 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: It is not yet known if there will be a plan to make IPD available, if the plan changes, the research team will share the plan details.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cannabidiol in the Treatment of Opioid Use Disorder
ClinicalTrials.gov ID: NCT06206291
Acronym / sponsor ID: STUDY-21-00607
Conditions: Opioid Use Disorder
Keywords: CBD, Cannabidiol, Methadone, Buprenorphine, Opioid Use Disorder, OUD
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: Yasmin HurdUniversity, hospital or other
Study start: 4 Oct 2023 (actual)
Primary completion: 4 Apr 2024 (actual)
Study completion: 4 Apr 2024 (actual)
First posted: 16 Jan 2024 (actual)
Results: Posted 18 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Methadone CBD	Active comparator	Drug: Cannabidiol (CBD) 200mg, Drug: Cannabidiol (CBD) 400mgCBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Methadone Placebo	Placebo comparator	Drug: Placebo, Drug: Cannabidiol (CBD) 400mgMatching placebo.in first dosing period and CBD 400mg in second dosing period
Buprenorphine CBD	Active comparator	Drug: Cannabidiol (CBD) 200mg, Drug: Cannabidiol (CBD) 400mgCBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
Buprenorphine Placebo	Placebo comparator	Drug: Placebo, Drug: Cannabidiol (CBD) 400mgMatching placebo.in first dosing period and CBD 400mg in second dosing period

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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:

Key exclusion criteria (16 listed)

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 (except for opioid and nicotine/tobacco) in the past 3 months, based on the MINI interview, that would preclude safe participation in the study as determined by the study medical clinician.
Alcohol intoxication when arriving at the study site (i.e., positive alcohol breathalyzer / alcohol salivary strips / urine alcohol).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboMatching placebo twice daily for first 4 weeks	Drug	Buprenorphine Placebo, Methadone Placebo
Cannabidiol (CBD) 200mgFirst 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment.	Drug	Buprenorphine CBD, Methadone CBD
Cannabidiol (CBD) 400mgSecond 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment.	Drug	Buprenorphine CBD, Buprenorphine Placebo, Methadone CBD, Methadone Placebo

Primary outcome

Change in Visual Analog Scale for Craving (VASC)
Time frame: Baseline and 4 weeks
Cue-induced Visual Analog Scale for craving is used to measure subjective craving responses to a drug and neutral video cues evaluated in the clinic. Changes in craving from baseline (pre-cue to post-cue and pre-neutral cue to post-neutral cue) will be measured and compared. Total scale ranges from 0-10, with higher scores indicating extreme cravings.
Change in Visual Analog Scale Anxiety (VASA)
Time frame: Baseline and 4-weeks
Cue-induced Visual Analog Scale Anxiety is used to measure subjective anxiety responses to a drug and neutral video cue evaluated in the clinic. Changes in anxiety from baseline (pre-cue to post-cue and pre-neutral cue to post-neutral cue) will be measured and compared. Total scale from 0-10, with higher score indicating extreme anxiety.
Percentage of Participants With Positive Urine Toxicology
Time frame: 4-weeks
Percentage of participants with positive urine toxicology for illicit opioid use at 4 weeks.
Systematic Assessment for Treatment Emergent Events (SAFTEE)
Time frame: weekly for 8 weeks (Baseline, Week 1, 2, 3, 4, 5, 6, 7, and 8)
Systematic Assessment for Treatment Emergent Events (SAFTEE) is used to measure safety and tolerability. SAFTEE is a side effect self-report assessment scale that consists of 56 potential side effects. Participants rate how bothersome each side effect is on a scale of "none" (0), "mild" (1), "moderate" (2), "severe" (3). Total score ranges 0 - 168, higher scores indicate a higher level of side effect burden.

24 secondary outcomes

Change in Visual Analog Scale for Craving (VASC)
Time frame: 4-weeks and 8-weeks
Change in Visual Analog Scale Anxiety (VASA)
Time frame: 4-weeks and 8-weeks
Change in Percentage of Participants With Positive Urine Toxicology
Time frame: 4 weeks and 8 weeks
Change in Heroin Craving Questionnaire Short Form (HCQ-SF-14)
Time frame: baseline and 4-weeks, 4-weeks and 8-weeks
Change in Generalized Anxiety Disorder Scale (GAD-7)
Time frame: Baseline and 4-weeks, 4-weeks and 8-weeks
Duration of Participant First Illicit Opioid Abstinence
Time frame: any time during study, 8 weeks
Change in Patient Health Questionnaire (PHQ-9)
Time frame: baseline and 4-weeks, 4-weeks and 8-weeks
Positive and Negative Affect Schedule (PANAS-SF)
Time frame: baseline, 4-weeks and 8-weeks, post-cue collected within 10 minutes of pre-cue
Change in Heart Rate
Time frame: baseline and 8-weeks
Change in Blood Pressure
Time frame: baseline and 8-weeks
Change in Body Temperature
Time frame: baseline and 8-weeks
Change in Oxygen Level
Time frame: baseline and 8-weeks
Change in Cue-induced Salivary Cortisol Levels
Time frame: Baseline and 4-weeks, 4-weeks and 8-weeks
Sleep Duration in Minutes Per Night
Time frame: up to 8-weeks
Change in Insomnia Severity Index (ISI)
Time frame: baseline and 8-weeks
Change in The Digit Span Test Subtest of the Wechsler Adult Intelligence Scale 4th Edition
Time frame: baseline and 8-weeks
Change in The Symptom Check List 90 (SCL-90)
Time frame: baseline and 8-weeks
Change in Percentage of Participants With THC Positive in Urine.
Time frame: baseline and 4-weeks, 4-weeks and 8 weeks
Change in Plasma Level of THC Positive in Blood.
Time frame: baseline and 4-weeks, 4-weeks and 8 weeks
Change in Concentration of Methadone Metabolites in Blood
Time frame: baseline and 4-weeks, 4-weeks and 8-weeks
Change in Concentration of Buprenorphine Metabolites in Blood
Time frame: baseline and 4-weeks, 4-weeks and 8 weeks
Number of Participants Remaining in Treatment
Time frame: up to 8 weeks
Change Methadone Dosage of Opioid Agonist Treatment
Time frame: baseline and 8 weeks
Number of CBD-COOH Positive Blood Toxicology
Time frame: 4 weeks

Results and safety

Results posted to the registry on 18 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Methadone CBD 200mg, Then CBD 400mg	32	29
Methadone Placebo, Then CBD 400mg	30	26
Buprenorphine CBD 200mg, Then CBD 400mg	8	8
Buprenorphine Placebo, Then CBD 400mg	6	5

Primary outcome: Change in Visual Analog Scale for Craving (VASC)

Time frame: Baseline and 4 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Methadone CBD 200mg, Then CBD 400mg n = 29	Methadone Placebo, Then CBD 400mg n = 26	Buprenorphine CBD 200mg, Then CBD 400mg n = 8	Buprenorphine Placebo, Then CBD 400mg n = 5
Change in VASC in response to neutral cue	0.54 (1.8)	0.31 (1.6)	0.25 (0.5)	-0.20 (0.8)
Change in VASC in response to drug cue	0.07 (2.2)	0.04 (1.1)	0.13 (1.0)	-1.20 (3.3)

Population analysed: Results provide for participants who responded to the respective cues at both timepoints.

Primary outcome: Change in Visual Analog Scale Anxiety (VASA)

Time frame: Baseline and 4-weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Methadone CBD n = 29	Methadone Placebo n = 26	Buprenorphine CBD n = 8	Buprenorphine Placebo n = 5
Change in VASA in response to neutral cue	0.82 (1.9)	0.00 (1.3)	1.25 (1.7)	0.60 (1.8)
Change in VASA in response to drug cue	-0.48 (2.8)	0.25 (1.4)	1.00 (1.7)	0.80 (5.2)

Population analysed: Results provide for participants who responded to the respective cues at both timepoints.

Primary outcome: Percentage of Participants With Positive Urine Toxicology

Time frame: 4-weeks. Number. Unit: Percentage of participants

Measure	Methadone CBD n = 29	Methadone Placebo n = 26	Buprenorphine CBD n = 8	Buprenorphine Placebo n = 5
Value	75.90	80.80	12.5	20.00

Population analysed: Results provide for participants who provided urine sample at 4 weeks.

Primary outcome: Systematic Assessment for Treatment Emergent Events (SAFTEE)

Time frame: weekly for 8 weeks (Baseline, Week 1, 2, 3, 4, 5, 6, 7, and 8). Mean (Standard Deviation). Unit: score on a scale

Measure	Methadone CBD n = 32	Methadone Placebo n = 30	Buprenorphine CBD n = 8	Buprenorphine Placebo n = 6
Baseline	0.03 (0.2)	0.03 (0.2)	0.00 (0.00)	0.00 (0.00)
Week 1	0.16 (0.5)	0.39 (0.8)	0.25 (0.5)	0.50 (0.8)
Week 2	0.07 (0.4)	0.11 (0.3)	0.13 (0.4)	0.20 (0.4)
Week 3	0.00 (0.00)	0.08 (0.3)	0.00 (0.0)	0.00 (0.0)
Week 4	0.03 (0.2)	0.04 (0.2)	0.00 (0.0)	0.00 (0.0)
Week 5	0.31 (0.6)	0.46 (0.9)	0.13 (0.4)	0.00 (0.0)
Week 6	0.14 (0.4)	0.15 (0.5)	0.38 (0.5)	0.00 (0.0)
Week 7	0.00 (0.0)	0.04 (0.2)	0.13 (0.5)	0.20 (0.4)

Population analysed: Result provided for participants who completed the assessment for the respective week.

24 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Methadone CBD 200mg	0 of 32 (0%)	12 of 32 (37.5%)	0 of 32
Methadone Placebo	0 of 30 (0%)	21 of 30 (70%)	0 of 30
Methadone CBD 400mg	0 of 55 (0%)	38 of 55 (69.1%)	0 of 55
Buprenorphine CBD 200mg	0 of 8 (0%)	5 of 8 (62.5%)	0 of 8
Buprenorphine Placebo	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Buprenorphine CBD 400mg	0 of 13 (0%)	6 of 13 (46.2%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. It is not yet known if there will be a plan to make IPD available, if the plan changes, the research team will share the plan details.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yasmin Hurd, PhD principal investigator

Icahn School of Medicine at Mount Sinai

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cannabidiol (CBD) 200mg and Cannabidiol (CBD) 400mg in people with Opioid Use Disorder, run by Yasmin Hurd at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Visual Analog Scale for Craving (VASC) (time frame: Baseline and 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06206291.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.