Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain
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.
| Condition(s) | Chronic Pain, Chronic Insomnia, Opioid Use |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | 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 depr |
| Ages | 18 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | University of South Florida |
| Locations | Tampa, Florida, United States |
| Start date | 2024-12-11 |
| NCT ID | NCT06345872 |
| Official listing | https://clinicaltrials.gov/study/NCT06345872 |