Chronic PainEarly Phase 1NCT04587791

Cannabidiol in Opioid Use Disorder and Chronic Pain

A Early Phase 1 study testing 400 mg Cannabidiol, 800 mg Cannabidiol and 1200 mg Cannabidiol in people with Chronic Pain and Opioid Use Disorder, run by Yale University 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

Search all trials

Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Chronic Pain, Opioid Use Disorder
What is being tested?: 400 mg Cannabidiol, 800 mg Cannabidiol and 1200 mg Cannabidiol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 23 participants
Where: 1 siteUnited States
Study dates: 8 Dec 2021to 19 Mar 2025
Phase: Early Phase 1
Are there results?: None posted in the registry

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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males and females, Veterans and non-Veterans, aged between 18 and 70 years old.
Diagnosed with OUD and currently enrolled in methadone 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 injections, contraceptive subdermal implants, intrauterine devices, or surgical contraception methods. Acceptable contraception for males includes condoms or surgical contraception methods.

Who cannot join

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.
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' cannabinoid use will be assessed using a quantitative point-of-care urine 11-nor-9-carboxy-THC concentration test with a cut-off of ≤ 50 mg/mL. If a participant tests greater than ≤50 mg/mL, they will be asked to abstain for an additional 7 to 14 days. If 14 days after their initial THC concentration test the participant continues to test positive, they will not be allowed to participate in the study.
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 inhibitors (SNRIs) (e.g. venlafaxine, duloxetine), gabapentinoids, tricyclic antidepressants (e.g., nortriptyline, amitriptyline), anticonvulsant medications (e.g., topiramate, carbamazepine)). Only participants who are on stable doses (i.e., consistent daily administration of the medication for at least three months at the same dose following the last dose change, either increase or decrease) of these medications, and whose dosing schedules allow participation in the study visits, thus excluding instances of single-dose or temporary dosing of the medication, will be eligible as determined by principal investigator. If possible, the morning dose will be administered after the study visit.

Show all 12Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Department of Veterans Affairs Hospital
West Haven, Connecticut, 06516

Other trials in United States

About this study

Official title: Cannabidiol Pharmacotherapy for Co-occurring Opioid Use Disorder and Chronic Pain

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. 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.

Read the detailed description

Participants with comorbid opioid use disorder (OUD) and non-cancer chronic pain for at least 6 months, currently receiving methadone will be enrolled. Across four test sessions, prior to their daily methadone dose, and thus at trough plasma levels of opioid, participants will receive oral CBD (400 mg, 800 mg, 1200 mg) or placebo. Subsequently, all participants will undergo laboratory testing of opioid-related outcomes.

The order of study medication administration will be counterbalanced order to minimize carryover effects. On the initial screening day and at the end of medication treatment, blood will be drawn to determine serum drug levels. Participants will be thoroughly evaluated by a physician prior to discharge on each experimental session. One week after the last study medication dose, participants will be conducted by phone for a follow-up session.

Conditions: Chronic Pain, Opioid Use Disorder
Being tested: 400 mg Cannabidiol, 800 mg Cannabidiol, 1200 mg Cannabidiol, Beta carotene oral solution without CBD
Keywords: Methadone, Cannabidiol, Pain
Medical subject headings: Chronic Pain, Opioid-Related Disorders, Pain

What participants receive

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

400 mg CannabidiolDrug
Also called CBD, Epidiolex
Participants will receive 400 mg CBD
800 mg CannabidiolDrug
Also called CBD, Epidiolex
Participants will receive 800 mg CBD
1200 mg CannabidiolDrug
Also called CBD, Epidiolex
Participants will receive 1200 mg CBD
Beta carotene oral solution without CBDDrug
Also called Placebo
Participants will receive beta carotene oral solution without CBD (placebo)

Study groups in NCT04587791
Study group	Role	What they receive
CBD 400 mg	Active comparator	CBD 400 mg Receives: Drug: 400 mg Cannabidiol
CBD 800 mg	Active comparator	CBD 800mg Receives: Drug: 800 mg Cannabidiol
CBD 1200 mg	Active comparator	CBD 1200 mg Receives: Drug: 1200 mg Cannabidiol
Beta carotene oral solution	Placebo comparator	Beta carotene oral solution without CBD Receives: Drug: Beta carotene oral solution without CBD

What is being measured

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

Safety and tolerability of CBD measured by the Systematic Assessment for Treatment Emergent Effects (SAFTEE)
The SAFTEE is a multi-symptom checklist that has been used successfully in the investigators previous studies to assess and monitor any adverse events and possible side effects of study medications. It includes information regarding the severity of any presenting symptoms (0= none, 1= mild, 2= moderate, and 3= severe), as well as the course of action taken by the study staff in response. The SAFTEE is administered before the administration of CBD at baseline, (timepoint -30 minutes) and 4 hours after the administration of CBD (timepoint +240 minutes) during each test session. Data will be presented as the number of participants that reported symptoms on the SAFTEE.
Measured: Baseline (30 minutes before the administration of CBD) and +240 minutes after the administration of CBD
Abuse potential of CBD measured by the Drug Effects Questionnaire (DEQ)
The DEQ will be administered to assess the abuse potential of CBD. The DEQ is a 10-item questionnaire used to assess the subjective effects of psychoactive drugs. Each item is a visual analogue scale (VAS) ranging from 0-100. The questionnaire is used to measure whether a subject feels the drug "feels high", likes or dislikes the effects, and whether they want more of the drug. The primary DEQ outcome will be the Stimulatory Effects subscale, obtained by averaging participants responses to the items: "Feel High"; "Feel Stimulated"; and "Feel the Drug Strength".
Measured: Baseline (30 minutes before the administration of CBD), and every 30 minutes after the administration of CBD (up to +240 minutes)
Cognitive effects of CBD measured by the Hopkins Verbal Learning Test (HVLT)
The HVLT will be used to assess the cognitive effects of CBD. The primary outcomes will be immediate and delayed recall, which index verbal memory. The HVLT consists of a 12-item word list, composed of four words from each of the three semantic categories. The participant is instructed to listen carefully as the examiner reads the word list and attempt to memorize the words. The participants' free recall of the list is recorded. The same procedure is repeated for two more trials (immediate recall). After approximately 15 minutes the participant will be asked to recall as many words from the list as they can without the list being re-read to them (delayed recall).
Measured: +210 minutes after the administration of CBD
Cognitive/psychomotor effects of CBD measured by the Continuous Performance Test (CPT)
The cognitive/psychomotor effects of CBD will be assessed using the Continuous Performance Test (CPT). CPT is a computerized neuropsychological assessment that measures participants sustained and selective attention. For the CPT, the primary outcome will be the throughput score, which indexes attention/working memory accuracy (i.e. percent of correct responses) and speed (i.e. reaction time).
Measured: +210 minutes after the administration of CBD

Secondary outcomes (8)

Pain sensitivity measured by Quantitative Sensory Testing (QST) Pain threshold and tolerance
Pain threshold and tolerance will be assessed using a comprehensive QST battery. This is a reliable, dynamic, and computerized method of quantifying distinct mechanisms of the pain experience. QST measures are sensitive to the effects of cannabinoids, important biomarkers of chronic pain, and predictors of the pain treatment response. Threshold: the temperature the participant first begins to feel pain (average pain threshold). Tolerance: the temperature when the participant can no longer tolerate the stimuli. The temperature ranges from 37° Celsius to 50° Celsius. A lower temperature represents a lower pain threshold/tolerance and a higher temperature represents a higher pain threshold/tolerance.
Measured: Baseline (30 minutes before the administration of CBD), +120 minutes and +240 minutes after the administration of CBD.
Pain sensitivity measured by change in Quantitative Sensory Testing (QST) Conditioned Pain Modulation (CPM)
CPM indexes top-down pain inhibition, by leveraging the "pain inhibits pain phenomena". In CPM, a test stimulus is rated on a -100 to +100 Numeric Rating Scale (NRS) for pain both alone and during a concurrent conditioning stimulus applied elsewhere on the body. The CPM Score is the difference between these two ratings. CPM score is a Difference (Delta): Pain rating (test stimulus alone) - Pain rating (test stimulus with conditioning stimulus) Interpretation: Higher (more positive) values indicate greater pain inhibition.
Measured: Baseline (30 minutes before the administration of CBD), +120 minutes and +240 minutes after the administration of CBD.
Pain sensitivity measured by Quantitative Sensory Testing (QST) Temporal Summation of Pain (TSP)
TSP involves the repeated administration of noxious stimuli, indexing bottom-up pain facilitation. Therefore, TSP measures the increase in pain perception with repeated noxious stimuli, calculated as the area under the curve (AUC) of pain ratings over time during repeated stimulation. Higher TSP scores indicate worse outcomes (greater pain facilitation/central sensitization), while lower TSP scores indicate better outcomes (less pain facilitation/central sensitization). The TSP AUC values represent the cumulative pain experience during repeated stimulation (VAS units*seconds), where larger values reflect greater temporal summation of pain, which is associated with central nervous system sensitization and chronic pain conditions.
Measured: Baseline (30 minutes before the administration of CBD), +120 minutes and +240 minutes after the administration of CBD.
Response to Quantitative Sensory Testing (QST) battery measured by Pain Visual Analog Scale (VAS)
The pain VAS will be used by participants as a secondary rating scale for pain severity pain testing. This scale ranges from 0 to 100 and contains of a horizontal line, anchored by verbal descriptors of "no pain" and "pain as bad as it could be". Participants will place a vertical line at the point that best indicates their present pain.
Measured: Baseline (30 minutes before the administration of CBD), +120 minutes and +240 minutes after the administration of CBD.
Pain Catastrophizing measured by the Pain Catastrophizing Scale (PCS)
The PCS is a 13-item self-report scale designed to measure negative thoughts and feelings associated with pain. Each item is rated on a 5-point scale: 0 (Not at all) to 4 (all the time). Total scores range from 0 to 52, with higher scores indicating greater catastrophizing. The PCS contains three subscales: magnification (scores ranging from 0-12), rumination (scores ranging from 0-16), and helplessness (scores ranging from 0-24).
Measured: Baseline (30 minutes before the administration of CBD)
Opioid craving measured by change in the Heroin Craving Questionnaire - Short Form 14 (HCQ-SF-14)
The HCQ-SF-14 consists of 14 statements about the respondent's feelings and thoughts about using heroin as he or she is completing the questionnaire (i.e., right now). Each of the 14 items is scored on a scale from 1 (Strongly Disagree) to 7 (Strongly Agree). The HCQ-SF-14 score is obtained by adding the scores of all 14 statements and dividing the total by 14. Higher scores on the HCQ-SF-14 indicate a stronger craving for heroin. The HCQ-14 was administered before (+150 minutes) and after (+155 minutes) participants watched a cue-induced craving video. The difference of the two HCQ-14 scores (post - pre) will be used to index cue-elicited craving.
Measured: Average difference of scores from before cue-induced craving video (+150 minutes) and after cue-induced craving video (+155 minutes)
Opioid craving measured by the Subjective Opiate Withdrawal Scale (SOWS)
The SOWS is a 16-item, participant-administered questionnaire designed to rate the intensity of opioid withdrawal symptoms. It assesses symptoms on a 0-4 scale ("not at all" to "extremely"), with total scores of 1-10 indicating mild, 11-20 moderate, and 21-30 severe withdrawal.
Measured: Baseline (30 minutes before the administration of CBD), +30 minutes, +90 minutes, +150 minutes, +210 minutes, and +240 minutes after the administration of CBD
Negative affect measured by the Positive and Negative Affect Schedule (PANAS)
The PANAS is a 20-item self-report questionnaire listing adjectives relating to Positive Affect (PA) (e.g., excited, inspired) and Negative Affect (NA) (e.g., distressed, afraid). Items are rated on a Likert scale ranging from 1 "Very slightly or not at all" to 5 "extremely". The PANAS yields separate PA and NA scores, each ranging from 10 to 50. Higher PA scores indicate more positive feelings, while higher NA scores indicate more negative feelings. These scores are used to track emotional states over time. The PANAS will be used to measure the effects of CBD on mood.
Measured: Baseline (30 minutes before the administration of CBD), and every 30 minutes after the administration of CBD (up to +240 minutes)

Timeline

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

8 Dec 202119 Mar 2025

First posted14 Oct 2020
Study start8 Dec 2021
Primary completion19 Mar 2025
Study completion19 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic PainStudies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
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: Early Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: Participants will receive CBD (400 mg, 800 mg, 1200 mg) or placebo.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04587791
Sponsor's protocol ID: JD001
Other IDs: 2000029286, 1K23DA052682-01
Status last verified: Oct 2026
First submitted: 2 Oct 2020
Last updated: 13 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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?

See locations

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All Chronic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cannabidiol Pharmacotherapy for Co-occurring Opioid Use Disorder and Chronic Pain
ClinicalTrials.gov ID: NCT04587791
Acronym / sponsor ID: JD001
Conditions: Chronic Pain, Opioid Use Disorder
Keywords: Methadone, Cannabidiol, Pain
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: VA Connecticut Healthcare System, National Institute on Drug Abuse (NIDA)
Study start: 8 Dec 2021 (actual)
Primary completion: 19 Mar 2025 (actual)
Study completion: 19 Mar 2025 (actual)
First posted: 14 Oct 2020 (actual)
Results: Not posted in the source record

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: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4
Model description: Participants will receive CBD (400 mg, 800 mg, 1200 mg) or placebo.

Arm	Type	Receives
CBD 400 mg	Active comparator	Drug: 400 mg CannabidiolCBD 400 mg
CBD 800 mg	Active comparator	Drug: 800 mg CannabidiolCBD 800mg
CBD 1200 mg	Active comparator	Drug: 1200 mg CannabidiolCBD 1200 mg
Beta carotene oral solution	Placebo comparator	Drug: Beta carotene oral solution without CBDBeta carotene oral solution without CBD

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Males and females, Veterans and non-Veterans, aged between 18 and 70 years old.
Diagnosed with OUD and currently enrolled in methadone 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.

Key exclusion criteria (12 listed)

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.
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' cannabinoid use will be assessed using a quantitative point-of-care urine 11-nor-9-carboxy-THC concentration test with a cut-off of ≤ 50 mg/mL. If a participant tests greater than ≤50 mg/mL, they will be asked to abstain for an additional 7 to 14 days. If 14 days after their initial THC concentration test the participant continues to test positive, they will not be allowed to participate in the study.

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
400 mg CannabidiolAlso: CBD, EpidiolexParticipants will receive 400 mg CBD	Drug	CBD 400 mg
800 mg CannabidiolAlso: CBD, EpidiolexParticipants will receive 800 mg CBD	Drug	CBD 800 mg
1200 mg CannabidiolAlso: CBD, EpidiolexParticipants will receive 1200 mg CBD	Drug	CBD 1200 mg
Beta carotene oral solution without CBDAlso: PlaceboParticipants will receive beta carotene oral solution without CBD (placebo)	Drug	Beta carotene oral solution

Primary outcome

Safety and tolerability of CBD measured by the Systematic Assessment for Treatment Emergent Effects (SAFTEE)
Time frame: Baseline (30 minutes before the administration of CBD) and +240 minutes after the administration of CBD
The SAFTEE is a multi-symptom checklist that has been used successfully in the investigators previous studies to assess and monitor any adverse events and possible side effects of study medications. It includes information regarding the severity of any presenting symptoms (0= none, 1= mild, 2= moderate, and 3= severe), as well as the course of action taken by the study staff in response. The SAFTEE is administered before the administration of CBD at baseline, (timepoint -30 minutes) and 4 hours after the administration of CBD (timepoint +240 minutes) during each test session. Data will be presented as the number of participants that reported symptoms on the SAFTEE.
Abuse potential of CBD measured by the Drug Effects Questionnaire (DEQ)
Time frame: Baseline (30 minutes before the administration of CBD), and every 30 minutes after the administration of CBD (up to +240 minutes)
The DEQ will be administered to assess the abuse potential of CBD. The DEQ is a 10-item questionnaire used to assess the subjective effects of psychoactive drugs. Each item is a visual analogue scale (VAS) ranging from 0-100. The questionnaire is used to measure whether a subject feels the drug "feels high", likes or dislikes the effects, and whether they want more of the drug. The primary DEQ outcome will be the Stimulatory Effects subscale, obtained by averaging participants responses to the items: "Feel High"; "Feel Stimulated"; and "Feel the Drug Strength".
Cognitive effects of CBD measured by the Hopkins Verbal Learning Test (HVLT)
Time frame: +210 minutes after the administration of CBD
The HVLT will be used to assess the cognitive effects of CBD. The primary outcomes will be immediate and delayed recall, which index verbal memory. The HVLT consists of a 12-item word list, composed of four words from each of the three semantic categories. The participant is instructed to listen carefully as the examiner reads the word list and attempt to memorize the words. The participants' free recall of the list is recorded. The same procedure is repeated for two more trials (immediate recall). After approximately 15 minutes the participant will be asked to recall as many words from the list as they can without the list being re-read to them (delayed recall).
Cognitive/psychomotor effects of CBD measured by the Continuous Performance Test (CPT)
Time frame: +210 minutes after the administration of CBD
The cognitive/psychomotor effects of CBD will be assessed using the Continuous Performance Test (CPT). CPT is a computerized neuropsychological assessment that measures participants sustained and selective attention. For the CPT, the primary outcome will be the throughput score, which indexes attention/working memory accuracy (i.e. percent of correct responses) and speed (i.e. reaction time).

8 secondary outcomes

Pain sensitivity measured by Quantitative Sensory Testing (QST) Pain threshold and tolerance
Time frame: Baseline (30 minutes before the administration of CBD), +120 minutes and +240 minutes after the administration of CBD.
Pain sensitivity measured by change in Quantitative Sensory Testing (QST) Conditioned Pain Modulation (CPM)
Time frame: Baseline (30 minutes before the administration of CBD), +120 minutes and +240 minutes after the administration of CBD.
Pain sensitivity measured by Quantitative Sensory Testing (QST) Temporal Summation of Pain (TSP)
Time frame: Baseline (30 minutes before the administration of CBD), +120 minutes and +240 minutes after the administration of CBD.
Response to Quantitative Sensory Testing (QST) battery measured by Pain Visual Analog Scale (VAS)
Time frame: Baseline (30 minutes before the administration of CBD), +120 minutes and +240 minutes after the administration of CBD.
Pain Catastrophizing measured by the Pain Catastrophizing Scale (PCS)
Time frame: Baseline (30 minutes before the administration of CBD)
Opioid craving measured by change in the Heroin Craving Questionnaire - Short Form 14 (HCQ-SF-14)
Time frame: Average difference of scores from before cue-induced craving video (+150 minutes) and after cue-induced craving video (+155 minutes)
Opioid craving measured by the Subjective Opiate Withdrawal Scale (SOWS)
Time frame: Baseline (30 minutes before the administration of CBD), +30 minutes, +90 minutes, +150 minutes, +210 minutes, and +240 minutes after the administration of CBD
Negative affect measured by the Positive and Negative Affect Schedule (PANAS)
Time frame: Baseline (30 minutes before the administration of CBD), and every 30 minutes after the administration of CBD (up to +240 minutes)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
Individual participant dataSharing planned: No

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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.

Joao De Aquino, M.D. principal investigator

Yale University

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

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing 400 mg Cannabidiol, 800 mg Cannabidiol and 1200 mg Cannabidiol in people with Chronic Pain and Opioid Use Disorder, run by Yale University 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 8 inclusion and 12 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 13 Oct 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Safety and tolerability of CBD measured by the Systematic Assessment for Treatment Emergent Effects (SAFTEE) (time frame: Baseline (30 minutes before the administration of CBD) and +240 minutes after the administration of CBD). 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 NCT04587791.

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 13 Oct 2026.