Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain

NCT ID
NCT06345872
Registry status
Recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
University of South Florida
Conditions
Chronic Insomnia, Chronic Pain, Opioid Use

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: SPIN Opioid: Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain

Enrollment: 165 participants (Estimated).

What is being studied

  • Behavioral: CBT-I
  • Other: Tapered Withdrawal
  • Intervention: Therapeutics
  • Behavioral: Treatment as usual

Who may be eligible

Ages
18 Years to no maximum
Sex
All
Healthy volunteers accepted
Yes

ClinicalTrials.gov lists the following eligibility 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

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: United States

  • Florida, United States: 1

Sample of listed locations

  • University of South Florida — Tampa, Florida, 33612, United States — Recruiting

Study details

Start date
December 11, 2024
Primary completion date
January 1, 2028
Completion date
July 1, 2028
First posted
April 3, 2024
Collaborators
National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT06345872
Registry last updated
April 21, 2026
QualifiedStudies registry data refreshed
October 2, 2026
QualifiedStudies record fetched
October 2, 2026

View NCT06345872 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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