Evaluation of a Specific Transdermal Cannabidiol Product for Chronic Musculoskeletal Joint Pain.

NCT05002114 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: IND_CBD_001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Double-blind, randomized into two arms (TC and TP): patients get either topical cannabidiol or topical placebo up to three times daily. Inclusion criteria will be chronic joint pain with intent to treat or currently treated with opioids. Exclusion criteria will include current cannabis use, severe medical illness or lacking in capacity to be involved in study. TC and TP will be prescribed for use TID in predefined dosages and quantities.

Conditions

Musculoskeletal Joint Pain

Outcome Measures

Primary Outcomes (3)

• Change in PGI-S

  Patient Global Impression of Severity Scale from 1 to 7 with higher scores indicating worse condition

  Two time points, before treatment and after 4 weeks.

• Change in PGI-C

  Patient Global Impression of Change Scale from 1 to 7 with higher scores indicating worse condition

  Two time points, before treatment and after 4 weeks.

• Change in QOLS

  Quality of Life Scale Scale from 16 to 112, with higher scores indicating better condition

  Two time points, before treatment and after 4 weeks.

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

Does not get active topical CBD. Instead, gets an identical placebo-containing topical agent.

Other: Placebo

Active Group

EXPERIMENTAL

Does get active topic CBD.

Drug: Cannabidiol

Interventions

Cannabidiol DRUG

Topical CBD cream - special formulation

Active Group

Placebo OTHER

Not the drug

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of chronic musculoskeletal joint pain (arthritis, traumatic arthritis, osteoarthritis)
• Adults ages 18 and over.
• Medically stable without significant medical illness that would preclude treatment with either pharmacologic agent.
• Have a safe, stable, living environment.

You may not qualify if:

• Unable to consent for research project.
• Individuals less than 18 years of age.
• Individuals with rheumatoid or other autoimmune types of arthritis.
• Individuals diagnosed with SUD especially cannabis, as this may confound results.

Sponsors & Collaborators

• Louisiana State University Health Sciences Center Shreveport: lead

MeSH Terms

Interventions

Cannabidiol

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind, randomized, placebo-controlled.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Director, Louisiana Addiction Research Center

Model Details: double-blind, randomized, placebo-controlled.

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 12, 2021
• Study Start: January 1, 2023
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: July 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share