Recruiting
Phase 2

Cannabinoid Product

Sponsor:

Staci Gruber, Ph.D.

Code:

NCT03984565

Conditions

Chronic Pain

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Cannabidiol

Placebo

Study Details

Brief 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.

Conditions

Chronic Pain

Study ID

NCT03984565

Start date

Jun 27, 2024

Status verified date

Mar, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cannabidiol Treatment Arm

High-CBD sublingual product administered three times daily for the treatment period.

placebo comparator: Placebo Treatment Arm

Placebo sublingual product administered three times daily for the treatment period.

Interventions

Cannabidiol

High-CBD, low-THC sublingual product formulated in palm oil

Placebo

Placebo sublingual product formulated in palm oil with supplemental terpenes to match CBD product.

Primary outcome measure

  • Change in pain ratings on a Numerical Rating Scale (NRS) [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Deniz, Grace, Alexa

(617) 855-3338cbdstudy@mclean.harvard.edu

More Information

Sponsor

Staci Gruber, Ph.D.

Last update posted

Mar 17, 2025

Last verified

Mar, 2025

Keywords

  • Cannabidiol
  • Medical Cannabis
  • Industrial Hemp

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by Staci Gruber, Ph.D. on 2025-03-17.