Improving sleep and reducing opioid use in people with chronic pain
SPIN Opioid: Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain
This study is testing if a sleep therapy can help people with chronic pain sleep better and use fewer opioids.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 165 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of South Florida Academic / other |
| Locations | 1 site (Tampa, Florida) |
| Trial ID | NCT06345872 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate two behavioral interventions for chronic insomnia in individuals suffering from chronic pain who are also using prescribed opioid medications. It focuses on the Cognitive Behavioral Treatment for Insomnia (CBT-I) as a potential method to improve sleep quality and reduce pain, thereby facilitating a gradual tapering of opioid use. The study hypothesizes that enhancing sleep and decreasing arousal will lead to normalized brain activation and reduced pain severity, ultimately aiding in opioid withdrawal. Participants will be randomized to receive either CBT-I, standard treatment, or a tapered withdrawal approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with chronic widespread pain and insomnia who are currently prescribed opioids and wish to reduce or eliminate their use.
Not a fit: Patients with cognitive impairments, other severe sleep disorders, or untreated major psychopathology may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new approach to managing chronic pain and insomnia while reducing reliance on opioids.
How similar studies have performed: Previous studies have shown that cognitive behavioral treatment for insomnia can improve sleep and pain in individuals with chronic pain, but this specific approach of combining it with opioid tapering is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tampa, Florida
- University of South Florida — Tampa, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Christina S McCrae, PhD — University of South Florida
- Study coordinator: Christina S McCrae, PhD
- Email: christinamccrae@usf.edu
- Phone: 8139741804
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.