NCT04298554

Brief Summary

The aim of this study is to determine whether the cannabinoids taken orally in the form of cannabidiol (CBD oil-a major non-psychoactive component of marijuana) vs placebo (hemp oil) will provide pain relief and improved jaw function in those who suffer from either myofascial pain disorder and/or arthralgia of the temporomandibular region.

  1. 1.Primary Objectives To determine if the consumption of CBD oil is superior to placebo for the improvement in jaw pain.
  2. 2.Secondary Objectives To determine if the consumption of CBD oil is superior to placebo for the improvement in function of the temporomandibular joint.
  3. 3.Exploratory Objectives To determine if there are any adverse effects that result from the consumption of CBD oil or placebo.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

August 6, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2022

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

1.8 years

First QC Date

March 4, 2020

Last Update Submit

March 9, 2023

Conditions

TMJ DisorderMyofacial PainTMD

Keywords

CBDTMJTMD

Outcome Measures

Primary Outcomes (1)

  • Change in baseline in pain, as measured by the Visual Analog Scale (VAS)

    Scores are measured from 1-100mm VAS. The VAS ranges from 0 to 100 with O indicating no pain and higher scores indicating a greater pain.

    Baseline, 3 weeks, 7 weeks, and 11 weeks

Secondary Outcomes (1)

  • Change in jaw functional limitations as measured by the jaw functional limitation scale.

    Baseline, 3 weeks, 7 weeks, and 11 weeks

Study Arms (2)

CBD Oil

EXPERIMENTAL

CBD PURE CBD OIL 20mg/1ml concentration - 1 ml (20mg) qd PO, hold under tongue for 1 minute and swallow daily

Other: CBD Oil

Placebo (hemp oil)

PLACEBO COMPARATOR

CBD PURE Hemp Oil- 1 ml qd PO, hold under tongue for 1 minute and swallow daily

Other: Hemp Oil

Interventions

CBD OilOTHER

CBD PURE CBD OIL 20mg/1ml concentration

Also known as: Cannabinoids
CBD Oil
Hemp OilOTHER

CBD PURE HEMP OIL

Placebo (hemp oil)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women 18-70 years of age
  • Ability to give informed consent
  • Arthralgia of the temporomandibular joint as defined according to the RDC/TMD criteria (see below chart)\[3\] and/or Myofascial pain of masticatory muscles as defined according to the RDC/TMD criteria (see below chart)\[3\]
  • Baseline pain must be greater than 3/10 as self-reported on the VAS

You may not qualify if:

  • Allergy to study drug
  • Traumatic injury of masticatory muscles or temporomandibular joint within last 12 months
  • Mandibular fracture within last 12 months
  • Pregnancy or breast feeding
  • Initiation of additional treatment of MPD within the past 1 months
  • Baseline pain less than 3/10 as self-reported on the VAS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10028, United States

Location

MeSH Terms

Conditions

Temporomandibular Joint DisordersFacial Pain

Interventions

Cannabinoidshempseed oil

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TerpenesHydrocarbonsOrganic Chemicals

Study Officials

  • Gwendolyn Reeve, DMD FACS

    Weill Cornell New York Presbyterian Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2020

First Posted

March 6, 2020

Study Start

August 6, 2020

Primary Completion

May 29, 2022

Study Completion

May 29, 2022

Last Updated

March 14, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)