RECRUITING

Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain

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Conditions

Chronic PainChronic InsomniaOpioid UseCBT-I

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-04
Study Completion:2028-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06345872

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18+ yrs
  2. * willing to be randomized,
  3. * can read/understand English
  4. * diagnosed with chronic widespread pain and insomnia (as described below)
  5. * prescribed opioid medication for 1+ mo, 3+ times per week
  6. * desire to reduce or eliminate opioid use
  7. * written agreement from physician prescribing opioid medication
  8. * no prescribed or OTC sleep meds for 1+ mo, or stabilized on meds for 6+ wks
  1. * unable to provide informed consent
  2. * cognitive impairment (MMSE \<26)
  3. * sleep disorder other than insomnia \[i.e., sleep apnea (apnea/hypopnea index, AHI \>15)
  4. * Periodic Limb Movement Disorder (myoclonus arousals per hour \>15)\]
  5. * bipolar or seizure disorder (due to risk of sleep restriction treatment)
  6. * other severe, untreated major psychopathology except for depression or anxiety (e.g.,suicidal ideation/intent, psychotic disorders)
  7. * psychotropic or other medications (e.g., beta-blockers) that alter pain or sleep (medications prescribed for pain or sleep are allowed)
  8. * participation in other non-pharmacological treatment for pain, sleep, or mood outside the current trial
  9. * internal metal objects or electrical devices
  10. * pregnancy
  11. * presumptive/confirmed lumbar nerve root compression
  12. * confirmed lumbar spinal stenosis
  13. * \<6 mos post-back surgery
  14. * other spinal disorders

Contacts and Locations

Study Contact

Christina S McCrae, PhD
CONTACT
(813) 974-1804
christinamccrae@usf.edu

Principal Investigator

Christina S McCrae, PhD
PRINCIPAL_INVESTIGATOR
University of South Florida

Study Locations (Sites)

University of South Florida
Tampa, Florida, 33612
United States

Collaborators and Investigators

Sponsor: University of South Florida

  • Christina S McCrae, PhD, PRINCIPAL_INVESTIGATOR, University of South Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04
Study Completion Date2028-07

Study Record Updates

Study Start Date2024-04
Study Completion Date2028-07

Terms related to this study

Keywords Provided by Researchers

  • Chronic pain
  • Chronic insomnia
  • Opioid use
  • CBT-I

Additional Relevant MeSH Terms

  • Chronic Pain
  • Chronic Insomnia
  • Opioid Use