Chronic PainPhase 2NCT03984565
PAIN: A Project Assessing the Impact of a Novel Cannabinoid Product
A Phase 2 study testing Cannabidiol in people with Chronic Pain, run by Staci Gruber, Ph.D. at 1 site in United States.
Trial summary
This study is a clinical trial of a high-cannabidiol (CBD) sublingual product compared to placebo for 9 weeks in patients with chronic pain conditions. The study will assess the impact of CBD on chronic pain symptoms, conventional medication use, clinical state, quality of life, cognition, and biomarkers. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Cannabidiol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2024to Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has provided informed consent
- Subject is 21 or older
- Subject is fluent in English
- Subject endorses a musculoskeletal chronic pain condition including, but not limited to, chronic pain due to injury, arthritis (including osteoarthritis and rheumatoid arthritis), bursitis, etc.
Who cannot join
- Non-fluent English speakers
- Estimated IQ < 75
- A history of head injury or loss of consciousness greater than 5 minutes
- Currently uses CBD products regularly
- Female subjects will be excluded if they have a positive urine pregnancy test, are trying to become pregnant, or are currently breastfeeding
- Presence of a serious or unstable medical illness, including liver, kidney, or cardiovascular disease (hyper/hypotension, cardiac disorders), or neurological disorder (including seizure disorder)
- Primary neuropathic pain or cancer-related pain; patients experiencing neuropathic pain secondary to musculoskeletal pain will be allowed to enter the study
- Disclosure of a genetic polymorphism affecting CYP2C9 function
Trial locations and contacts
1 site in 1 country.
About this study
This study is a clinical trial of a high-cannabidiol (CBD) sublingual product compared to placebo for 9 weeks in patients with chronic pain conditions. The study will assess the impact of CBD on chronic pain symptoms, conventional medication use, clinical state, quality of life, cognition, and biomarkers.
Read the detailed description
Cannabis sativa has been used medicinally to treat a wide range of disorders for thousands of years. Cannabis is comprised of more than 100 cannabinoids, including D9-tetrahydrocannabinol (THC), the major intoxicating constituent, and cannabidiol (CBD), the major non-intoxicating constituent that has a number of potential therapeutic properties. Although a wide range of medical cannabis (MC) and hemp products (containing less than 0.3% THC) are used by consumers for a variety of medical indications, little is known about the direct impact of individual cannabinoids and constituent ratios on the symptoms that cause patients to seek treatment.
Chronic pain is one of the most common indications for MC use, and several studies have yielded compelling data suggesting that MC and its constituents may have analgesic and anti-inflammatory properties, suggesting that cannabinoids may have the potential to treat chronic pain. This investigation will involve a placebo-controlled crossover trial of a hemp-derived high-CBD, low-THC sublingual product in patients with chronic pain; patients will be assessed at baseline and over 69weeks of treatment with CBD or placebo on measures of clinical state, including pain and related symptoms, conventional medication use, and cognition, and provide samples for analysis of inflammatory markers.
- Conditions
- Chronic Pain
- Being tested
- Cannabidiol, Placebo
- Keywords
- Cannabidiol, Medical Cannabis, Industrial Hemp
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
Also called CBD
High-CBD, low-THC sublingual product formulated in palm oil
PlaceboDrug
Placebo sublingual product formulated in palm oil with supplemental terpenes to match CBD product.
| Study group | Role | What they receive |
|---|---|---|
| Cannabidiol Treatment Arm | Experimental | High-CBD sublingual product administered three times daily for the treatment period. Receives: Drug: Cannabidiol |
| Placebo Treatment Arm | Placebo comparator | Placebo sublingual product administered three times daily for the treatment period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain ratings on a Numerical Rating Scale (NRS)
The NRS is an 11-point scale on which subjects rate their pain by choosing a number between 0 (no pain) and 10 (worst possible pain). Lower scores indicate less pain.
Measured: 6 weeks
Secondary outcomes (5)
Change in pain ratings on the Brief Pain Inventory (BPI)
The BPI contains 9 questions that assess the severity of pain, how much relief is provided by treatment, and the functional impact of the pain within the last 24 hours. Lower scores are better.
Measured: 6 weeks
Change in ratings on the Pain Self-Efficacy Questionnaire (PSEQ)
The PSEQ contains several questions assessing the patients' confidence in carrying out certain activities despite their pain on a 7-point scale ranging from 0 (not at all confident) to 6 (completely confident). Higher scores are better.
Measured: 6 weeks
Change in ratings on the Pain Distress Scale (PDS)
The PDS is an 11-point scale one where subjects rate their pain by level of distress the pain causes on a scale of 0 to 10. Lower scores are better.
Measured: 6 weeks
Change in ratings on the Pain Disability Index (PDI)
On the PDI, the subject rates how their pain affects 7 different areas of their life on a scale of the level of disability that their pain causes, from "no disability" to "worst disability". Lower scores are better.
Measured: 6 weeks
Change in Conventional Medication Use
Change in conventional medication use, including opioids, will be assessed and analyzed. Changes in dose and frequency of conventional medication use will be quantified.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start27 Jun 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
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.
- 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Staci Gruber, Ph.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Etheridge Foundation
- Responsible party
- Sponsor-investigator, Staci Gruber, Ph.D., Mclean Hospital
- Investigators
- Staci Gruber, Ph.D., Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984565
- Sponsor's protocol ID
- 2023P001774
- Status last verified
- Sep 2026
- First submitted
- 7 Jun 2019
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PAIN: A Project Assessing the Impact of a Novel Cannabinoid Product
- ClinicalTrials.gov ID
- NCT03984565
- Acronym / sponsor ID
- 2023P001774
- Conditions
- Chronic Pain
- Keywords
- Cannabidiol, Medical Cannabis, Industrial Hemp
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Staci Gruber, Ph.D.University, hospital or other
- Collaborators
- Etheridge Foundation
- Study start
- 27 Jun 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 13 Jun 2019 (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.
This study is a clinical trial of a high-cannabidiol (CBD) sublingual product compared to placebo for 9 weeks in patients with chronic pain conditions. The study will assess the impact of CBD on chronic pain symptoms, conventional medication use, clinical state, quality of life, cognition, and biomarkers.
Detailed description
Cannabis sativa has been used medicinally to treat a wide range of disorders for thousands of years. Cannabis is comprised of more than 100 cannabinoids, including D9-tetrahydrocannabinol (THC), the major intoxicating constituent, and cannabidiol (CBD), the major non-intoxicating constituent that has a number of potential therapeutic properties. Although a wide range of medical cannabis (MC) and hemp products (containing less than 0.3% THC) are used by consumers for a variety of medical indications, little is known about the direct impact of individual cannabinoids and constituent ratios on the symptoms that cause patients to seek treatment.
Chronic pain is one of the most common indications for MC use, and several studies have yielded compelling data suggesting that MC and its constituents may have analgesic and anti-inflammatory properties, suggesting that cannabinoids may have the potential to treat chronic pain. This investigation will involve a placebo-controlled crossover trial of a hemp-derived high-CBD, low-THC sublingual product in patients with chronic pain; patients will be assessed at baseline and over 69weeks of treatment with CBD or placebo on measures of clinical state, including pain and related symptoms, conventional medication use, and cognition, and provide samples for analysis of inflammatory markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cannabidiol Treatment Arm | Experimental | Drug: CannabidiolHigh-CBD sublingual product administered three times daily for the treatment period. |
| Placebo Treatment Arm | Placebo comparator | Drug: PlaceboPlacebo sublingual product administered three times daily for the treatment period. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject has provided informed consent
- Subject is 21 or older
- Subject is fluent in English
- Subject endorses a musculoskeletal chronic pain condition including, but not limited to, chronic pain due to injury, arthritis (including osteoarthritis and rheumatoid arthritis), bursitis, etc.
Key exclusion criteria (8 listed)
- Non-fluent English speakers
- Estimated IQ < 75
- A history of head injury or loss of consciousness greater than 5 minutes
- Currently uses CBD products regularly
- Female subjects will be excluded if they have a positive urine pregnancy test, are trying to become pregnant, or are currently breastfeeding
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 |
|---|---|---|
| CannabidiolAlso: CBDHigh-CBD, low-THC sublingual product formulated in palm oil | Drug | Cannabidiol Treatment Arm |
| PlaceboPlacebo sublingual product formulated in palm oil with supplemental terpenes to match CBD product. | Drug | Placebo Treatment Arm |
Primary outcome
Change in pain ratings on a Numerical Rating Scale (NRS)
Time frame: 6 weeks
The NRS is an 11-point scale on which subjects rate their pain by choosing a number between 0 (no pain) and 10 (worst possible pain). Lower scores indicate less pain.
5 secondary outcomes
Change in pain ratings on the Brief Pain Inventory (BPI)
Time frame: 6 weeks
Change in ratings on the Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: 6 weeks
Change in ratings on the Pain Distress Scale (PDS)
Time frame: 6 weeks
Change in ratings on the Pain Disability Index (PDI)
Time frame: 6 weeks
Change in Conventional Medication Use
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Staci Gruber, Ph.D. principal investigator
Mclean Hospital
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 in people with Chronic Pain, run by Staci Gruber, Ph.D. 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 4 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 30 Sep 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?
This study is still under way. Results are not available in the source record yet.
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 pain ratings on a Numerical Rating Scale (NRS) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2026.