NCT03984565

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2 chronic-pain

Timeline
4mo left

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Jun 2024Sep 2026

First Submitted

Initial submission to the registry

June 7, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 13, 2019

Completed
5 years until next milestone

Study Start

First participant enrolled

June 27, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

2.2 years

First QC Date

June 7, 2019

Last Update Submit

March 24, 2026

Conditions

Chronic Pain

Keywords

CannabidiolMedical CannabisIndustrial Hemp

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 weeks

Secondary Outcomes (5)

  • Change in pain ratings on the Brief Pain Inventory (BPI)

    6 weeks

  • Change in ratings on the Pain Self-Efficacy Questionnaire (PSEQ)

    6 weeks

  • Change in ratings on the Pain Distress Scale (PDS)

    6 weeks

  • Change in ratings on the Pain Disability Index (PDI)

    6 weeks

  • Change in Conventional Medication Use

    6 weeks

Study Arms (2)

Cannabidiol Treatment Arm

EXPERIMENTAL

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

Drug: Cannabidiol

Placebo Treatment Arm

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

CannabidiolDRUG

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

Also known as: CBD
Cannabidiol Treatment Arm
PlaceboDRUG

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

Placebo Treatment Arm

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Officials

  • Staci Gruber, Ph.D.

    Mclean Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Staci Gruber, Ph.D.

CONTACT

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

Rosie Smith, M.S.

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, Marijuana Investigations for Neuroscientific Discovery; Director, Cognitive and Clinical Neuroimaging Core; Associate Professor of Psychiatry, Harvard Medical School

Study Record Dates

First Submitted

June 7, 2019

First Posted

June 13, 2019

Study Start

June 27, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

March 30, 2026

Record last verified: 2026-03

Locations

US(1)