Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06345872

Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain

Led by University of South Florida · Updated on 2026-04-21

165

Participants Needed

1

Research Sites

185 weeks

Total Duration

On this page

Sponsors

U

University of South Florida

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this study is to test two behavioral interventions for chronic insomnia in individuals with chronic pain and use prescribed opioid medication to treat their chronic pain.

CONDITIONS

Official Title

Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older
  • Willing to be randomized
  • Able to read and understand English
  • Diagnosed with chronic widespread pain and insomnia
  • Prescribed opioid medication for at least 1 month, taken 3 or more times per week
  • Desire to reduce or eliminate opioid use
  • Written agreement from the prescribing physician for opioid medication
  • Not using prescribed or over-the-counter sleep medications for at least 1 month, or stabilized on sleep medications for 6 or more weeks
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent
  • Cognitive impairment (Mini-Mental State Exam score less than 26)
  • Sleep disorders other than insomnia, including sleep apnea (apnea/hypopnea index greater than 15) or Periodic Limb Movement Disorder (myoclonus arousals per hour greater than 15)
  • Bipolar disorder or seizure disorder
  • Severe untreated major mental health conditions besides depression or anxiety, such as suicidal thoughts or psychotic disorders
  • Use of psychotropic or other medications that affect pain or sleep, except those prescribed specifically for pain or sleep
  • Participation in other non-drug treatments for pain, sleep, or mood outside this trial
  • Presence of internal metal objects or electrical devices
  • Pregnancy
  • Presumptive or confirmed lumbar nerve root compression
  • Confirmed lumbar spinal stenosis
  • Less than 6 months since back surgery
  • Other spinal disorders

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of South Florida

Tampa, Florida, United States, 33612

Actively Recruiting

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Research Team

C

Christina S McCrae, PhD

CONTACT

B

Britani Holland, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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