Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain
University of South Florida · with National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA) · NCT06345872
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 165
- US sites recruiting
- 1
- Study start
- December 11, 2024
- Record last updated
- April 21, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study 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.
Being studied: CBT-I; Treatment as usual; Tapered Withdrawal
Conditions: Chronic Pain; Chronic Insomnia; Opioid Use
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 18+ yrs
- willing to be randomized,
- can read/understand English
- diagnosed with chronic widespread pain and insomnia (as described below)
- prescribed opioid medication for 1+ mo, 3+ times per week
- desire to reduce or eliminate opioid use
- written agreement from physician prescribing opioid medication
- no prescribed or OTC sleep meds for 1+ mo, or stabilized on meds for 6+ wks
Exclusion Criteria
- unable to provide informed consent
- cognitive impairment (MMSE \<26)
- sleep disorder other than insomnia [i.e., sleep apnea (apnea/hypopnea index, AHI >15)
- Periodic Limb Movement Disorder (myoclonus arousals per hour >15)]
- bipolar or seizure disorder (due to risk of sleep restriction treatment)
- other severe, untreated major psychopathology except for depression or anxiety (e.g.,suicidal ideation/intent, psychotic disorders)
- psychotropic or other medications (e.g., beta-blockers) that alter pain or sleep (medications prescribed for pain or sleep are allowed)
- participation in other non-pharmacological treatment for pain, sleep, or mood outside the current trial
- internal metal objects or electrical devices
- pregnancy
- presumptive/confirmed lumbar nerve root compression
- confirmed lumbar spinal stenosis
- \<6 mos post-back surgery
- other spinal disorders
Recruiting US locations
University of South Florida
Tampa, FL 33612
Site contact: Christina S McCrae, PhD · 813-974-1804 · christinamccrae@usf.edu
Study contacts (from the official record)
- Christina S McCrae, PhD · 8139741804 · christinamccrae@usf.edu
- Britani Holland, PhD · 8139741804 · blalone@usf.edu
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