CompletedPhase 2

Is Topical CBD Effective in Treating Thumb Joint Arthritis

United States18 participantsStarted 2020-07-28

Plain-language summary

Rationale: CBD is commonly being used as an over-the-counter treatment for arthritis-related pain, however no clinical trial has been performed to establish efficacy. Hypothesis: CBD is more effective than placebo for relieving pain and improving patient-reported outcomes for thumb basal joint arthritis. Study Design: The study design with be a double-blind, randomized controlled trial with crossover. Treatment will be blinded to the subjects and investigators. Patients will be randomly assigned 2 weeks of the CBD or control and then crossover to the other condition for 2 additional weeks. Patients will apply the cream at the thumb base twice daily for 1 hour. Subjects will be advised to observe for physiologic changes, skin changes, or other adverse effects.

Who can participate

Age range18 Years

SexALL

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

✓. Provision of signed and dated informed consent form.
✓. Stated willingness to comply with all study procedures and availability for the duration of the study.
✓. Male or female, aged 18 years or older.
✓. Females of childbearing potential must have a negative urine and blood pregnancy test at Screening and a negative urine pregnancy test before study drug is administered. Females must abstain from sex or use a highly effective method of contraception during the period from Screening to administration of study drug and for 30 days after the last dose of study medication. Standard acceptable methods include abstinence or the use of a highly effective method of contraception, including; hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom with spermicide, vasectomy, intrauterine device. If females are of non-child bearing potential, they must be post-menopausal defined as: age \> 55 with no menses within the past 12 months, or history of hysterectomy, or history of bilateral oophorectomy, or bilateral tubal ligation.
✓. Males must consent to use a medically acceptable method of contraception throughout the entire study period and for 90 days after their last study drug application. They must agree to not donate sperm for 90 days after their last study drug application.
✓. Presence of radiographically confirmed diagnosis of thumb basal joint arthritis.

Exclusion criteria

What they're measuring

Change in Hand Strength During Intervention and at Follow-up.

Timeframe: Change from baseline to 2 weeks

Change in the PROMIS Upper Extremity Tests During Intervention and at Follow-up.

Timeframe: Change from baseline to 2 weeks

Change in Kapandji Score

Timeframe: Change from baseline to 2 weeks

Change in Hand Range of Motion

Timeframe: Change from baseline to 2 weeks

Trial details

NCT IDNCT04611347

SponsorUniversity of Virginia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-01-21

Results submitted2025-04-08

View on ClinicalTrials.gov More CBD trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

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

✓. Provision of signed and dated informed consent form.
✓. Stated willingness to comply with all study procedures and availability for the duration of the study.
✓. Male or female, aged 18 years or older.
✓. Females of childbearing potential must have a negative urine and blood pregnancy test at Screening and a negative urine pregnancy test before study drug is administered. Females must abstain from sex or use a highly effective method of contraception during the period from Screening to administration of study drug and for 30 days after the last dose of study medication. Standard acceptable methods include abstinence or the use of a highly effective method of contraception, including; hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom with spermicide, vasectomy, intrauterine device. If females are of non-child bearing potential, they must be post-menopausal defined as: age \> 55 with no menses within the past 12 months, or history of hysterectomy, or history of bilateral oophorectomy, or bilateral tubal ligation.
✓. Males must consent to use a medically acceptable method of contraception throughout the entire study period and for 90 days after their last study drug application. They must agree to not donate sperm for 90 days after their last study drug application.
✓. Presence of radiographically confirmed diagnosis of thumb basal joint arthritis.

Exclusion criteria

What they're measuring

Change in Hand Strength During Intervention and at Follow-up.

Timeframe: Change from baseline to 2 weeks

Change in the PROMIS Upper Extremity Tests During Intervention and at Follow-up.

Timeframe: Change from baseline to 2 weeks

Change in Kapandji Score

Timeframe: Change from baseline to 2 weeks

Change in Hand Range of Motion

Timeframe: Change from baseline to 2 weeks