SAMe for Osteoarthritis

(SAMe Trial)

Overseen By Zoe M Daudier

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Dartmouth-Hitchcock Medical Center

Must not be taking: Opioids, Gabapentin, Prednisone, SNRIs

Disqualifiers: Non-OA arthritis, Artificial joint, Bipolar, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to demonstrate the feasibility of evaluating SAMe tolerability, analgesic benefits, and daily functional improvement in patients with osteoarthritis of the hands compared to placebo. The secondary objective of this study is to generate preliminary data on discomfort, function, quality of life in patients with osteoarthritis of the hands when taking SAMe compared to placebo.

Will I have to stop taking my current medications?

Yes, you will need to stop taking your current over-the-counter or prescription pain relievers for two weeks before the study and remain off them during the study. If you are taking certain other medications like daily opioids, gabapentin, or prednisone, you may not be eligible to participate.

How does the drug SAMe differ from other treatments for osteoarthritis?

SAMe is a dietary supplement that offers pain relief and improved joint function similar to nonsteroidal anti-inflammatory drugs (NSAIDs) but with fewer side effects, making it a potentially safer option for managing osteoarthritis symptoms. ^{1 2 3 4 5}

Research Team

Scott C Jaynes, MD

Principal Investigator

Dartmouth-Hitchcock Medical Center

Eligibility Criteria

This trial is for adults over 40 with hand osteoarthritis, who have swelling or deformity in certain joints and are patients within the Dartmouth Health system. They must be willing to stop taking current pain medications two weeks before and during the study. People with artificial joints, other types of arthritis, bipolar disorder, or on certain medications like daily opioids cannot participate.

Inclusion Criteria

Current primary care provider within the Dartmouth Health system

*Objective inclusion criteria (see poster schematic): Swelling or deformity of 2 of the following ten joints: the 2nd and 3rd distal interphalangeal (DIP) of each hand, the 2nd and 3rd proximal interphalangeal (PIP) of each hand, and the 1st carpometacarpal joints of both hands.

Office visit at Dartmouth Health in the past 3 years

Exclusion Criteria

Patients taking prescription medications other than NSAIDs for their OA who are unable to stop their medication

Patients with diagnoses of arthritis from conditions other than OA

Patients whose symptomatic joint is an artificial joint

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1

Participants receive SAMe or placebo for 8 weeks

8 weeks

Weekly surveys

Washout

Participants undergo a washout period to clear the previous treatment

1 week

Treatment Phase 2

Participants receive the alternate treatment (SAMe or placebo) for 8 weeks

8 weeks

Weekly surveys

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Placebo
• S-Adenosyl-L-Methionine (Sam-E)

Trial Overview The trial is testing if S-Adenosyl-L-Methionine (SAMe) can help relieve pain and improve daily function in people with hand osteoarthritis compared to a placebo. Participants will receive either SAMe or a placebo and their pain levels, functionality, and quality of life will be monitored.

Participant Groups

Group I: S-Adenosyl-L-Methionine (SAMe) Experimental Treatment 2 Interventions

Participants receive S-Adenosyl-L-Methionine (SAMe) 400mg capsule orally twice daily for 8 weeks, followed by a 1 week washout period.

Group II: Placebo Placebo Group 2 Interventions

Participants receive identically appearing 400mg capsule orally twice daily for 8 weeks, followed by a 1 week washout period.

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

References

1. England pubmed.ncbi.nlm.nih.gov

S-adenosyl methionine (SAMe) versus celecoxib for the treatment of osteoarthritis symptoms: a double-blind cross-over trial. [ISRCTN36233495]. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Italian double-blind multicenter study comparing S-adenosylmethionine, naproxen, and placebo in the treatment of degenerative joint disease. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of S-adenosylmethionine (SAMe) for osteoarthritis. [2015]

4. Germany pubmed.ncbi.nlm.nih.gov

[Meta-analysis of the efficacy of adenosylmethionine and oxaceprol in the treatment of osteoarthritis]. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

S-adenosylmethionine in the treatment of osteoarthritis. Review of the clinical studies. [2019]