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

Primary Purpose

Chronic Pain, Chronic Insomnia, Opioid Use

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NiteCAPP HELPS
Tapered Withdrawal
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Tapered withdrawal, NiteCAPP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Missouri-Columbia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

NiteCAPP HELPS

Treatment as Usual

Arm Description

4 weeks of online CBT-I (1 session/week for 1 hour), followed by tapered withdrawal and motivational interviewing and check-ins.

Continuation of standard treatment for sleep and pain for 4 weeks, followed by tapered withdrawal and motivational interviewing and check-ins.

Outcomes

Primary Outcome Measures

Change in Insomnia Severity Index
Insomnia severity; score range 0-28 (low severity - high severity)
Change in Pain Intensity - Daily Electronic Sleep Diaries
Daily electronic dairies will record pain unpleasantness; range: 0-100 (none- most unpleasantness)
Change in Wake After Sleep Onset - Daily Electronic Sleep Diaries
Daily electronic dairies will record wake after sleep onset (number of minutes)
Change in Sleep Onset Latency- Daily Electronic Sleep Diaries
Daily electronic dairies will record sleep onset latency (number of minutes)
Change in Sleep Efficiency- Daily Electronic Sleep Diaries
Daily electronic dairies will record sleep efficiency
Change in Fatigue - Daily Electronic Sleep Diaries
Daily electronic dairies will record insomnia severity; range: 0-100 (no insomnia - most severe)
Change in Sleep and Pain Medication - Daily Electronic Sleep Diaries
Daily electronic dairies will record daily medication consumption
Change in Perceived Stress Scale
Perception of stress; score range: 0-40 (low stress - high stress)
Change in Peripheral Arousal
Heart Rate Variability (as measured by Holter-Monitoring)
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.
Change in Neural Imaging: Structural/Functional MRI/Diffusion Weighted Imaging
assessment of neural plasticity
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)
Change in Opioid Use (Quantitative)
Change in opioid use assessed with quantitative urine opioid panel
Change in Opioid Use (Self-Report)
Change in opioid use assessed with daily electronic diaries

Secondary Outcome Measures

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

Full Information

First Posted
November 8, 2021
Last Updated
March 8, 2023
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT05226026
Brief Title
NiteCAPP_HELPS_WD: Improving Sleep and Reducing Opioid Use in Chronic Pain Patients
Official Title
Impact of Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain on Central Pain Processing
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 31, 2022 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Chronic Insomnia, Opioid Use
Keywords
Tapered withdrawal, NiteCAPP

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NiteCAPP HELPS
Arm Type
Experimental
Arm Description
4 weeks of online CBT-I (1 session/week for 1 hour), followed by tapered withdrawal and motivational interviewing and check-ins.
Arm Title
Treatment as Usual
Arm Type
Other
Arm Description
Continuation of standard treatment for sleep and pain for 4 weeks, followed by tapered withdrawal and motivational interviewing and check-ins.
Intervention Type
Behavioral
Intervention Name(s)
NiteCAPP HELPS
Intervention Description
4 weeks of NiteCAPP (a digital version of CBT-I recently developed at Mizzou)
Intervention Type
Other
Intervention Name(s)
Tapered Withdrawal
Intervention Description
Gradual tapered withdrawal following CDC guidelines, with additional check-ins and motivational interviewing with a therapist.
Primary Outcome Measure Information:
Title
Change in Insomnia Severity Index
Description
Insomnia severity; score range 0-28 (low severity - high severity)
Time Frame
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Title
Change in Pain Intensity - Daily Electronic Sleep Diaries
Description
Daily electronic dairies will record pain unpleasantness; range: 0-100 (none- most unpleasantness)
Time Frame
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Title
Change in Wake After Sleep Onset - Daily Electronic Sleep Diaries
Description
Daily electronic dairies will record wake after sleep onset (number of minutes)
Time Frame
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Title
Change in Sleep Onset Latency- Daily Electronic Sleep Diaries
Description
Daily electronic dairies will record sleep onset latency (number of minutes)
Time Frame
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Title
Change in Sleep Efficiency- Daily Electronic Sleep Diaries
Description
Daily electronic dairies will record sleep efficiency
Time Frame
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Title
Change in Fatigue - Daily Electronic Sleep Diaries
Description
Daily electronic dairies will record insomnia severity; range: 0-100 (no insomnia - most severe)
Time Frame
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Title
Change in Sleep and Pain Medication - Daily Electronic Sleep Diaries
Description
Daily electronic dairies will record daily medication consumption
Time Frame
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Title
Change in Perceived Stress Scale
Description
Perception of stress; score range: 0-40 (low stress - high stress)
Time Frame
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Title
Change in Peripheral Arousal
Description
Heart Rate Variability (as measured by Holter-Monitoring)
Time Frame
5 mins at rest at baseline, 8 weeks, following completion of gradual tapered withdrawal
Title
Change in Pain Catastrophizing Scale
Description
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.
Time Frame
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Title
Change in Neural Imaging: Structural/Functional MRI/Diffusion Weighted Imaging
Description
assessment of neural plasticity
Time Frame
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Title
Change in Thermal Pain Response
Description
Participants will undergo quantitative sensory testing using a contact thermode applied to the left plantar, VAS scale for pain ()-100)
Time Frame
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Title
Change in Opioid Use (Quantitative)
Description
Change in opioid use assessed with quantitative urine opioid panel
Time Frame
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Title
Change in Opioid Use (Self-Report)
Description
Change in opioid use assessed with daily electronic diaries
Time Frame
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Secondary Outcome Measure Information:
Title
Change in State-Trait Anxiety Inventory (STAI)
Description
Trait and state anxiety; score range: 20-80 (low anxiety - high anxiety)
Time Frame
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Title
Change in Depression (Beck Depression Inventory-II)
Description
Depression severity; score range: 0-63 (normal - extreme depression)
Time Frame
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Title
Change in 36-Item Short Form Survey (SF-36)
Description
Self-reported health; score range: low quality of life to high quality of life
Time Frame
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Title
Change in Objective Wake After Sleep Onset (Actigraph)
Description
Wake after sleep onset via Actiwatch-2
Time Frame
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Title
Change in Objective Sleep Onset Latency (Actigraph)
Description
Sleep Onset Latency via Actiwatch-2
Time Frame
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Title
Change in Objective Sleep Efficiently (Actigraph)
Description
Sleep Efficiency via Actiwatch-2
Time Frame
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Title
Change in NIH Toolbox
Description
20 minute computerized cognitive tasks
Time Frame
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Title
Change in non-opioid substance use
Description
self reported changes in non-opioid substances via electronic diaries
Time Frame
Single administration at baseline, 8 weeks, following completion of gradual tapered withdrawal
Other Pre-specified Outcome Measures:
Title
Satisfaction Survey
Description
Experience with the assessments, procedures, and other features of the research study; score range: 9-90 (low satisfaction - high satisfaction)
Time Frame
Single administration at post-treatment - 8 weeks, following completion of gradual tapered withdrawal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of Missouri-Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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