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New treatment option for Chronic Pain
Official title Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain
ClinicalTrials.gov ID: NCT06345872
What this study is testing
- What it's testing
- 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.
- Which group you join is 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 and older. Healthy volunteers may be eligible.
You may be able to join if
- 18+ yrs
- willing to be assigned by chance,
- can read/understand English
- diagnosed with chronic widespread pain and insomnia (as described below)
- prescribed opioid medication for 1+ mo, 3+ times per week
You likely can't join if
- 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)
See the full eligibility criteria
- 18+ yrs
- willing to be assigned by chance,
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, 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 and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, 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.