Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain
RecruitingNot applicableNCT06345872
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- SPIN Opioid: Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain
- Conditions
- Interventions
- Behavioral: CBT-I
- Behavioral: Treatment as usual
- Other: Tapered Withdrawal
- Sponsor
- University of South Florida
- Collaborators
- National Institutes of Health (NIH); National Institute on Drug Abuse (NIDA)
- Start date
- 2024-12-11
- Primary completion
- 2028-01-01
- Sex
- All
- Age range
- from 18 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06345872