S-Asenosyl-L-Methionine vs Placebo for Osteoarthritis of the Hands (SAMe)

Dartmouth Health

Status and phase: Active, not recruiting; Phase 4

Conditions: Osteoarthritis Hand

Treatments: Drug: S-Adenosyl-L-Methionine (Sam-E); Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05363020

STUDY02001354

Details and patient eligibility

About

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.

Full description

At week 0, all patients giving written informed consent and meeting eligibility requirements will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to SAMe (400mg orally, twice daily) or placebo (400mg, twice daily) for 8 weeks. Followed by a one week wash out period followed by another 8 weeks of SAMe (400mg, twice daily) or placebo (400mg, twice daily) for 8 weeks (whichever was not given during the first 8 week period).

Participants will complete weekly surveys during the entire study regarding hand discomfort, functional limitations and side effects

Enrollment: 40 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Current primary care provider within the Dartmouth Health system

• Office visit at Dartmouth Health in the past 3 years

• Participants must be 40 or older at the time of signing the informed consent

• Participants have discomfort or functional limitations of one or both hands AND either:

  1. Objective findings of at least one hand meeting diagnostic criteria based on the American College of Rheumatology (ACR)* or
  2. Existing radiographic evidence of osteoarthritis as judged by a radiologist

• Patients taking OTC or prescription analgesics who are willing to stop their current analgesics for two weeks prior to study entry and remain off those medications over the course of the study

• *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.

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

• Patients with Bipolar Disorder

• Patients taking any of the following medications at study entry OR starting any of these medications during the study period:

  1. daily opioids (including tramadol or buprenorphine)
  2. gabapentin or pregabalin
  3. prednisone
  4. Prescription NSAIDs that they are unable to stop or topical diclofenac
  5. SNRI drugs (Effexor, Cymbalta, Fetzima, Pristiq)

• The participant has a condition or is in a situation which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

S-Adenosyl-L-Methionine (SAMe)

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: S-Adenosyl-L-Methionine (Sam-E)

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: S-Adenosyl-L-Methionine (Sam-E)