RecruitingPhase 2

PAIN: A Project Assessing the Impact of a Novel Cannabinoid Product

United States25 participantsStarted 2024-06-27

Plain-language 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.

Who can participate

Age range

21 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: * 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. Exclusion Criteria: * 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

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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 pain ratings on a Numerical Rating Scale (NRS)

Timeframe: 6 weeks

Trial details

NCT IDNCT03984565

SponsorStaci Gruber, Ph.D.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09

Contact for this trial

Staci Gruber, Ph.D.

617-855-2762 gruber@mclean.harvard.edu

View on ClinicalTrials.gov More Chronic Pain trials