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NCT Number: NCT06345872

Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Opioid therapy is commonly prescribed for patients with chronic widespread musculoskeletal pain, but offers questionable benefit for long-term pain management and is associated with arrhythmias, overdose, and death. Individuals with chronic pain experience high rates of comorbid chronic insomnia, arousal, and abnormal brain activation in response to painful stimuli. Research shows individuals with chronic pain exhibit increased brain activation in regions associated with pain modulation in response to painful stimuli compared to healthy controls. Withdrawal from opioids is difficult; and inadequately managed pain contributes to that difficulty. The Cognitive Activation Theory of Stress (CATS) tests the hypothesis that poor sleep and arousal lead to critical changes in brain activation that increase pain severity and lead to opioid use. Research shows cognitive behavioral treatment for insomnia (CBT-I, an evidence based intervention for chronic insomnia) improves sleep, arousal, abnormal brain activation, and pain in individuals with comorbid chronic pain and insomnia, but does not reduce opioid use. However, because CBT-I improves each of the mediators hypothesized to contribute to opioid use, it warrants examination as a neoadjuvant to gradual tapering of opioid medication. The proposed trial tests the novel hypothesis that improving sleep and decreasing arousal will lead to normalized brain activation and decreased pain prior to gradual tapering, which will facilitate reduced opioid use. This hypothesis is supported by theory (CATS) and empirical findings. It also reflects federal pain research priorities.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBT-I

Behavioral

Includes 8 weekly sessions of CBT-I and 2 bi-monthly boosters. Each session is to be completed individually by the participant in a single sitting (less than 45 mins). Each session should be completed in 7 days with next session released only after prior one completed.

Treatment as Usual

Behavioral

Includes 8 weekly sessions of standard treatment and 2 bi-monthly boosters. Each session is to be completed individually by the participant in a single sitting (less than 45 mins). Each session should be completed in 7 days with next session released only after prior one completed.

Tapered Withdrawal

Other

Individualized gradual tapered withdrawal following CDC guidelines, additional check-ins and motivational interviewing with a therapist.

Primary outcomes

  1. Change in Insomnia Severity Index

    Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

    Insomnia severity; score range 0-28 (low severity - high severity)

  2. Change in Pain Intensity - Daily Electronic Sleep Diaries

    Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

    Daily electronic dairies will record pain unpleasantness; range: 0-100 (none- most unpleasantness)

  3. Change in Wake After Sleep Onset - Daily Electronic Sleep Diaries

    Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

    Daily electronic dairies will record wake after sleep onset (number of minutes)

  4. Change in Sleep Onset Latency- Daily Electronic Sleep Diaries

    Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

    Daily electronic dairies will record sleep onset latency (number of minutes)

  5. Change in Sleep Efficiency- Daily Electronic Sleep Diaries

    Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

    Daily electronic dairies will record sleep efficiency

  6. Change in Fatigue - Daily Electronic Sleep Diaries

    Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

    Daily electronic dairies will record insomnia severity; range: 0-100 (no insomnia - most severe)

  7. Change in Sleep and Pain Medication - Daily Electronic Sleep Diaries

    Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

    Daily electronic dairies will record daily medication consumption)

  8. Change in Perceived Stress Scale

    Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

    Perception of stress; score range: 0-40 (low stress - high stress)

  9. Change in Peripheral Arousal

    Time frame: 5 mins at rest at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

    Heart Rate Variability (as measured by Holter-Monitoring)

  10. Change in Neural Imaging: Structural/Functional MRI/Diffusion Weighted Imaging

    Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

    Assessment of neural plasticity

  11. Change in Thermal Pain Response

    Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

    Participants will undergo quantitative sensory testing using a contact thermode applied to the left plantar, VAS scale for pain ()-100)

  12. Change in Opioid Use (Quantitative)

    Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

    Change in opioid use assessed with quantitative urine opioid panel

  13. Change in Opioid Use (Self-Report)

    Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

    Change in opioid use assessed with daily electronic diaries

Secondary outcomes

  1. Change in Objective Wake After Sleep Onset (Actigraph)

    Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

    Wake after sleep onset via GENEActiv

  2. Change in Objective Sleep Onset Latency (Actigraph)

    Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

    Sleep Onset Latency via GENEActiv

  3. Change in Objective Sleep Efficiency (Actigraph)

    Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

    Sleep Efficiency via GENEActiv

  4. Change in Neural Connectivity: Structural/Functional MRI/Diffusion Weighted Imaging

    Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

    Assessment of brain connectivity

  5. Short Inventory of Problems

    Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

    Modified from validated alcohol survey for opioid related problems

  6. Change in Pain Catastrophizing Scale

    Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

    The PCS yields a total score and three subscale scores assessing rumination, magnification and helplessness. Total score range from 0-52, with higher scores indicating greater pain catastrophizing.

Other outcomes

  1. Change in 36-Item Short Form Survey (SF-36)

    Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

    Self-reported health; score range: low quality of life to high quality of life

  2. Change in Depression (Beck Depression Inventory-II)

    Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

    Depression severity; score range: 0-63 (normal - extreme depression)

  3. Change in State-Trait Anxiety Inventory (STAI)

    Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

    Trait and state anxiety; score range: 20-80 (low anxiety - high anxiety)

  4. Medications/Substances Uses and Dosages

    Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

    Non-opioid pain/sleep medication use and dosage, tobacco, caffeine, alcohol, marijuana via daily electronic diaries

  5. Change in Subjective Opioid Withdrawal Scale (SOWS)

    Time frame: Single administration at 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

    Monitor changes in withdrawal symptoms

  6. Change in Opioid Cravings Scale

    Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

    Monitor of cravings related to opioid use

  7. Change in NIH Toolbox

    Time frame: Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal, and 6 month follow-up

    20-minute of two computerized cognitive tasks

Study contacts

Contact information is provided by the study sponsor or research team.

Britani Holland, PhD

CONTACT

[email protected]

8139741804

Christina S McCrae, PhD

CONTACT

[email protected]

8139741804

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Apr 3, 2024
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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