NiteCAPP_HELPS_WD: Improving Sleep and Reducing Opioid Use in Chronic Pain Patients

Impact of Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain on Central Pain Processing

This project addresses the highly significant problem of developing effective strategies for facilitating withdrawal from opioid medications. The proposed work is conceptualized within the context of a well-known theoretical framework (Cognitive Activation Theory of Stress), and the research questions are theory-driven. The team proposes to evaluate an innovative web-based version of CBT-I followed by tapered withdrawal in a randomized trial in comparison to a Treatment As Usual control followed by tapered withdrawal. The dependent measures have been well-selected to effectively evaluate the outcomes. The methodological details are rigorous.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Pain; Opioid Use; Chronic Insomnia
• Intervention / Treatment: Behavioral: NiteCAPP HELPS; Other: Tapered Withdrawal

Detailed Description

Individuals with chronic widespread pain are often prescribed opioid therapy. Unfortunately, opioid therapy offers questionable benefit for long-term pain management and is associated with other negative outcomes (arrhythmias, overdose, death). Individuals with chronic pain experience high rates of comorbid chronic insomnia, increased cognitive and physiological arousal, and disrupted executive function. They also often develop abnormal brain activation at rest and in response to painful stimuli (aka central sensitization). The investigator's research and other research shows individuals with chronic pain exhibit increased brain activation in the default mode network at rest and in regions associated with pain modulation in response to painful stimuli compared to healthy controls. Withdrawal from opioids can be difficult; and inadequately managed pain, abnormal brain activation, disrupted executive function, increased arousal, and poor sleep contribute to that difficulty. Consistent with the Cognitive Activation Theory of Stress (CATS), The investigators hypothesize that poor sleep and sustained arousal lead to critical changes in brain activation and disrupted executive function that increase pain and lead to opioid use. The proposed pilot will randomize 26 prescription opioid users who have chronic widespread pain and insomnia to 4 weeks of NiteCAPP (a digital version of CBT-I recently developed at Mizzou) or treatment as usual. They will then complete a gradual tapered withdrawal protocol for opioids.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65201
      • University of Missouri-Columbia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18+ yrs old
• willing to be randomized
• can read/understand English
• diagnosed with chronic widespread pain and insomnia
• 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 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 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 current 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NiteCAPP HELPS; 4 weeks of online CBT-I (1 session/week for 1 hour), followed by tapered withdrawal and motivational interviewing and check-ins.	Behavioral: NiteCAPP HELPS; 4 weeks of NiteCAPP (a digital version of CBT-I recently developed at Mizzou); Other: Tapered Withdrawal; Gradual tapered withdrawal following CDC guidelines, with additional check-ins and motivational interviewing with a therapist.
Other: Treatment as Usual; Continuation of standard treatment for sleep and pain for 4 weeks, followed by tapered withdrawal and motivational interviewing and check-ins.	Other: Tapered Withdrawal; Gradual tapered withdrawal following CDC guidelines, with additional check-ins and motivational interviewing with a therapist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Insomnia Severity Index	Insomnia severity; score range 0-28 (low severity - high severity)	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Pain Intensity - Daily Electronic Sleep Diaries	Daily electronic dairies will record pain unpleasantness; range: 0-100 (none- most unpleasantness)	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Wake After Sleep Onset - Daily Electronic Sleep Diaries	Daily electronic dairies will record wake after sleep onset (number of minutes)	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Sleep Onset Latency- Daily Electronic Sleep Diaries	Daily electronic dairies will record sleep onset latency (number of minutes)	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Sleep Efficiency- Daily Electronic Sleep Diaries	Daily electronic dairies will record sleep efficiency	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Fatigue - Daily Electronic Sleep Diaries	Daily electronic dairies will record insomnia severity; range: 0-100 (no insomnia - most severe)	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Sleep and Pain Medication - Daily Electronic Sleep Diaries	Daily electronic dairies will record daily medication consumption	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Perceived Stress Scale	Perception of stress; score range: 0-40 (low stress - high stress)	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Peripheral Arousal	Heart Rate Variability (as measured by Holter-Monitoring)	5 mins at rest at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Pain Catastrophizing Scale	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.	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Neural Imaging: Structural/Functional MRI/Diffusion Weighted Imaging	assessment of neural plasticity	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Thermal Pain Response	Participants will undergo quantitative sensory testing using a contact thermode applied to the left plantar, VAS scale for pain ()-100)	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Opioid Use (Quantitative)	Change in opioid use assessed with quantitative urine opioid panel	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Opioid Use (Self-Report)	Change in opioid use assessed with daily electronic diaries	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in State-Trait Anxiety Inventory (STAI)	Trait and state anxiety; score range: 20-80 (low anxiety - high anxiety)	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Depression (Beck Depression Inventory-II)	Depression severity; score range: 0-63 (normal - extreme depression)	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in 36-Item Short Form Survey (SF-36)	Self-reported health; score range: low quality of life to high quality of life	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Objective Wake After Sleep Onset (Actigraph)	Wake after sleep onset via Actiwatch-2	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Objective Sleep Onset Latency (Actigraph)	Sleep Onset Latency via Actiwatch-2	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in Objective Sleep Efficiently (Actigraph)	Sleep Efficiency via Actiwatch-2	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in NIH Toolbox	20 minute computerized cognitive tasks	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Change in non-opioid substance use	self reported changes in non-opioid substances via electronic diaries	Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction Survey	Experience with the assessments, procedures, and other features of the research study; score range: 9-90 (low satisfaction - high satisfaction)	Single administration at post-treatment - 8 weeks, following completion of gradual tapered withdrawal

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2022
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): June 1, 2024

Study Registration Dates

• First Submitted: November 8, 2021
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Actual): August 5, 2024
• Last Update Submitted That Met QC Criteria: August 1, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Tapered withdrawal; NiteCAPP
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Pain; Neurologic Manifestations; Chronic Pain; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2053802

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No