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Cannabidiol

Phase 1

Chronic Pain | Small molecule | Psychiatry |National Healthcare Corp.|Last Updated: Apr 14, 2026

Target and mechanism

Molecular targetCNR1
Target classNegative Allosteric Modulator
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment34

FDA Designations

No designations recorded

Clinical trial landscape

Cannabidiol · 1 trial · 2 indications

Early Phase 1 1
NCT04587791Cannabidiol in Opioid Use Disorder and Chronic PainChronic Pain
RECRUITING34 Analytics
EARLY_PHASE1RECRUITING
Cannabidiol in Opioid Use Disorder and Chronic Pain
Chronic PainUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability of CBD measured by the Systematic Assessment for Treatment Emergent Effects (SAFTEE)
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)
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)
+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)
+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).

Secondary Endpoints

Pain sensitivity measured by Quantitative Sensory Testing (QST) Pain threshold and tolerance
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)
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)
Baseline (30 minutes before the administration of CBD), +120 minutes and +240 minutes after the administration of CBD.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CBD 400 mgACTIVE_COMPARATORCBD 400 mg
CBD 800 mgACTIVE_COMPARATORCBD 800mg
CBD 1200 mgACTIVE_COMPARATORCBD 1200 mg
Beta carotene oral solutionPLACEBO_COMPARATORBeta carotene oral solution without CBD

Interventions

NameTypeDescription
400 mg CannabidiolDRUGParticipants will receive 400 mg CBD
800 mg CannabidiolDRUGParticipants will receive 800 mg CBD
1200 mg CannabidiolDRUGParticipants will receive 1200 mg CBD
Beta carotene oral solution without CBDDRUGParticipants will receive beta carotene oral solution without CBD (placebo)
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion 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 ≥ ...

Countries:United States
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Frequently asked questions about Cannabidiol

What is Cannabidiol used for?

Cannabidiol is an investigational small molecule being developed for chronic pain. It is currently in Phase 1 clinical development. The drug is being studied in patients with chronic pain and opioid use disorder, with a focus on pain management in this population.

What does Cannabidiol target?

Cannabidiol's molecular target has not been specified in the available information. It is a small molecule being studied for its effects on chronic pain, but the specific biological target or mechanism of action has not been disclosed.

Who makes Cannabidiol?

Cannabidiol is being developed by National Healthcare Corp. (ticker: NHC). The company is conducting clinical trials to evaluate the drug for chronic pain. The drug is currently in Phase 1 development.

What phase is Cannabidiol in?

Cannabidiol is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing trial is an early Phase 1 study that is currently recruiting participants.

What clinical trials is Cannabidiol in?

Cannabidiol is being studied in a Phase 1 clinical trial with the identifier NCT04587791. This trial is titled 'Cannabidiol in Opioid Use Disorder and Chronic Pain' and is recruiting 34 participants in the United States. The study is randomized, double-blind, and placebo-controlled.

Is Cannabidiol the same as 400 mg Cannabidiol?

Yes, Cannabidiol is also known as 400 mg Cannabidiol. This alternative name refers to the specific dosage form being studied in clinical trials. Both names refer to the same investigational drug being developed by National Healthcare Corp.