Improving sleep and reducing opioid use in people with chronic pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.