Recruiting PHASE4 Spine Fusion

New treatment option for Spine Fusion

Official title The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion

ClinicalTrials.gov ID: NCT05746143

What this study is testing

What is Zolpidem Tartrate 10 mg?

Zolpidem Tartrate 10 mg is an investigational medicine, being studied as a potential treatment for spine fusion.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
The purpose of this study is to evaluate if peri-operative zolpidem for posterior lumbar spinal fusion improves patient reported outcomes following surgery.
  • Phase 4: studies an already-approved treatment
  • You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 75

You may be able to join if

  • degenerative lumbar disease
  • age of 18-75
  • undergoing open primary one- to three-level lumbar fusion

You likely can't join if

  • currently use a sleep aid nightly
  • diagnosed with insomnia or sleep apnea
  • history of delirium with opiates or zolpidem
  • allergic to opiates or zolpidem
  • had previous lumbar spine surgery
  • undergoing minimally invasive lumbar fusion,
See the full eligibility criteria
Who can join
  • degenerative lumbar disease
  • age of 18-75
  • undergoing open primary one- to three-level lumbar fusion
What rules you out
  • currently use a sleep aid nightly
  • diagnosed with insomnia or sleep apnea
  • history of delirium with opiates or zolpidem
  • allergic to opiates or zolpidem
  • had previous lumbar spine surgery
  • undergoing minimally invasive lumbar fusion,
  • undergoing lumbar fusion for fracture, infection, tumor, or an inflammatory spondyloarthropathy

The study team makes the final eligibility decision.

Where it's taking place

  • Los Angeles, California, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.